Trial Outcomes & Findings for Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine (NCT NCT01641809)

Last Updated: 2020-01-30

Results Overview

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

244 participants

Primary outcome timeframe

Week 48

Results posted on

2020-01-30

Participant Flow

This was a multicenter, two part study in human immunodeficiency virus-1 (HIV-1) infected antiretroviral therapy (ART) naïve adult participants conducted across 48 sites in the United States (US) and Canada.

A total of 324 participants were screened, of which 80 failed screening and 244 participants were randomized to one of the four treatment arms in a ratio of 1:1:1:1. Of the 244 randomized participants, only 243 received atleast one dose of study treatment and comprised the Intent-to-Treat-Exposed (ITT-E) Population.

Participant milestones

Participant milestones
Measure	GSK1265744 10 mg Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Induction Phase (Day 1 to Week 24) STARTED	60	60	61	62
Induction Phase (Day 1 to Week 24) COMPLETED	52	53	55	47
Induction Phase (Day 1 to Week 24) NOT COMPLETED	8	7	6	15
Maintenance Phase (Week 24 to Week 96) STARTED	52	53	55	47
Maintenance Phase (Week 24 to Week 96) COMPLETED	46	48	52	41
Maintenance Phase (Week 24 to Week 96) NOT COMPLETED	6	5	3	6
Open-label (Week 96 to Week 324) STARTED	46	47	51	0
Open-label (Week 96 to Week 324) COMPLETED	30	35	43	0
Open-label (Week 96 to Week 324) NOT COMPLETED	16	12	8	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1265744 10 mg Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Induction Phase (Day 1 to Week 24) Withdrawal by Subject	1	1	0	1
Induction Phase (Day 1 to Week 24) Physician Decision	0	1	0	1
Induction Phase (Day 1 to Week 24) Lost to Follow-up	1	2	0	3
Induction Phase (Day 1 to Week 24) Protocol Violation	2	1	1	0
Induction Phase (Day 1 to Week 24) Lack of Efficacy	4	1	2	3
Induction Phase (Day 1 to Week 24) Adverse Event	0	1	3	7
Maintenance Phase (Week 24 to Week 96) Withdrawal by Subject	2	3	1	0
Maintenance Phase (Week 24 to Week 96) Physician Decision	0	1	0	0
Maintenance Phase (Week 24 to Week 96) Lost to Follow-up	2	0	1	2
Maintenance Phase (Week 24 to Week 96) Lack of Efficacy	1	1	0	2
Maintenance Phase (Week 24 to Week 96) Adverse Event	1	0	1	2
Open-label (Week 96 to Week 324) Withdrawal by Subject	2	3	1	0
Open-label (Week 96 to Week 324) Physician Decision	0	1	1	0
Open-label (Week 96 to Week 324) Lost to Follow-up	5	4	5	0
Open-label (Week 96 to Week 324) Site closed	1	0	0	0
Open-label (Week 96 to Week 324) Protocol Violation	1	1	0	0
Open-label (Week 96 to Week 324) Lack of Efficacy	4	1	0	0
Open-label (Week 96 to Week 324) Adverse Event	3	2	1	0

Baseline Characteristics

Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.	Total n=243 Participants Total of all reporting groups
Age, Continuous	34.0 Years STANDARD_DEVIATION 9.91 • n=93 Participants	34.4 Years STANDARD_DEVIATION 10.24 • n=4 Participants	36.2 Years STANDARD_DEVIATION 10.15 • n=27 Participants	35.6 Years STANDARD_DEVIATION 12.30 • n=483 Participants	35.1 Years STANDARD_DEVIATION 10.68 • n=36 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	1 Participants n=483 Participants	10 Participants n=36 Participants
Sex: Female, Male Male	57 Participants n=93 Participants	58 Participants n=4 Participants	57 Participants n=27 Participants	61 Participants n=483 Participants	233 Participants n=36 Participants
Race/Ethnicity, Customized African American (Af Am)/African Heritage (Her)	21 Participants n=93 Participants	17 Participants n=4 Participants	18 Participants n=27 Participants	20 Participants n=483 Participants	76 Participants n=36 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native (Nat)	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	4 Participants n=36 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Her	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants
Race/Ethnicity, Customized Asian-Japanese/East Asian/South East Asian Her	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants
Race/Ethnicity, Customized White	37 Participants n=93 Participants	39 Participants n=4 Participants	36 Participants n=27 Participants	39 Participants n=483 Participants	151 Participants n=36 Participants
Race/Ethnicity, Customized Af Am/Af Her and Asian and White	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Af Am/Af Her & Nat Hawaiian/other Pacific islander	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Af Am/Af Her & White	0 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native & White	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Asian & White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants

PRIMARY outcome

Timeframe: Week 48

Population: ITT-E Population

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm	80 Percentage of participants Interval 70.0 to 90.0	80 Percentage of participants Interval 70.0 to 90.0	87 Percentage of participants Interval 78.0 to 95.0	71 Percentage of participants Interval 60.0 to 82.0

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

Population: ITT-E Population

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA \<400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Baseline	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 2	87 Percentage of participants	80 Percentage of participants	84 Percentage of participants	68 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 4	93 Percentage of participants	93 Percentage of participants	93 Percentage of participants	68 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 8	93 Percentage of participants	92 Percentage of participants	92 Percentage of participants	79 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 12	90 Percentage of participants	85 Percentage of participants	89 Percentage of participants	73 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 16	93 Percentage of participants	87 Percentage of participants	93 Percentage of participants	81 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 24	93 Percentage of participants	87 Percentage of participants	92 Percentage of participants	79 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 26	80 Percentage of participants	80 Percentage of participants	87 Percentage of participants	71 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 28	85 Percentage of participants	83 Percentage of participants	85 Percentage of participants	73 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 32	87 Percentage of participants	85 Percentage of participants	89 Percentage of participants	73 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 36	87 Percentage of participants	85 Percentage of participants	90 Percentage of participants	73 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 40	87 Percentage of participants	85 Percentage of participants	90 Percentage of participants	73 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 48	83 Percentage of participants	85 Percentage of participants	89 Percentage of participants	73 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 60	80 Percentage of participants	77 Percentage of participants	87 Percentage of participants	71 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 72	77 Percentage of participants	75 Percentage of participants	85 Percentage of participants	68 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 84	77 Percentage of participants	77 Percentage of participants	85 Percentage of participants	68 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm Week 96	75 Percentage of participants	77 Percentage of participants	85 Percentage of participants	65 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Baseline	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 2	48 Percentage of participants	50 Percentage of participants	51 Percentage of participants	13 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 4	80 Percentage of participants	78 Percentage of participants	70 Percentage of participants	24 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 8	90 Percentage of participants	83 Percentage of participants	87 Percentage of participants	48 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 12	88 Percentage of participants	75 Percentage of participants	82 Percentage of participants	61 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 16	90 Percentage of participants	83 Percentage of participants	87 Percentage of participants	74 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 24	87 Percentage of participants	85 Percentage of participants	87 Percentage of participants	74 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 26	78 Percentage of participants	75 Percentage of participants	85 Percentage of participants	66 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 28	85 Percentage of participants	78 Percentage of participants	85 Percentage of participants	69 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 32	83 Percentage of participants	80 Percentage of participants	87 Percentage of participants	69 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 36	85 Percentage of participants	82 Percentage of participants	85 Percentage of participants	71 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 40	83 Percentage of participants	82 Percentage of participants	85 Percentage of participants	68 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 48	80 Percentage of participants	80 Percentage of participants	87 Percentage of participants	71 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 60	78 Percentage of participants	73 Percentage of participants	85 Percentage of participants	68 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 72	72 Percentage of participants	73 Percentage of participants	85 Percentage of participants	68 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 84	72 Percentage of participants	75 Percentage of participants	85 Percentage of participants	68 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 96	68 Percentage of participants	75 Percentage of participants	84 Percentage of participants	63 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 108	68 Percentage of participants	72 Percentage of participants	80 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 120	65 Percentage of participants	73 Percentage of participants	80 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 132	62 Percentage of participants	70 Percentage of participants	80 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 144	58 Percentage of participants	67 Percentage of participants	77 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 156	58 Percentage of participants	63 Percentage of participants	80 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 168	57 Percentage of participants	65 Percentage of participants	75 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 180	58 Percentage of participants	67 Percentage of participants	75 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 192	57 Percentage of participants	65 Percentage of participants	74 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 204	55 Percentage of participants	62 Percentage of participants	75 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 216	55 Percentage of participants	63 Percentage of participants	77 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 228	53 Percentage of participants	63 Percentage of participants	75 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 240	50 Percentage of participants	62 Percentage of participants	74 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 252	52 Percentage of participants	62 Percentage of participants	75 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 264	53 Percentage of participants	62 Percentage of participants	75 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 276	52 Percentage of participants	62 Percentage of participants	70 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 288	50 Percentage of participants	62 Percentage of participants	74 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 300	52 Percentage of participants	60 Percentage of participants	70 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm Week 312	52 Percentage of participants	52 Percentage of participants	70 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

Population: ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Baseline; n=60, 60, 61, 62	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 2; n=57, 56, 59, 59	51 Percentage of participants	54 Percentage of participants	53 Percentage of participants	14 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 4; n=58, 57, 59, 57	83 Percentage of participants	82 Percentage of participants	73 Percentage of participants	26 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 8; n=59, 56, 57, 55	92 Percentage of participants	89 Percentage of participants	93 Percentage of participants	55 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 12; n=58, 52, 57, 51	95 Percentage of participants	88 Percentage of participants	91 Percentage of participants	76 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 16; n=57, 54, 57, 52	95 Percentage of participants	94 Percentage of participants	93 Percentage of participants	87 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 20; n=56, 54, 56, 47	91 Percentage of participants	98 Percentage of participants	98 Percentage of participants	91 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 24; n=56, 53, 56, 48	93 Percentage of participants	98 Percentage of participants	95 Percentage of participants	96 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 26; n=48, 50, 53, 44	98 Percentage of participants	94 Percentage of participants	98 Percentage of participants	93 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 28; n=51, 52, 52, 45	100 Percentage of participants	94 Percentage of participants	100 Percentage of participants	96 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 32; n=52, 53, 55, 45	96 Percentage of participants	94 Percentage of participants	96 Percentage of participants	96 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 36; n=52, 53, 55, 45	98 Percentage of participants	96 Percentage of participants	95 Percentage of participants	98 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 40; n=52, 53, 55, 45	96 Percentage of participants	96 Percentage of participants	95 Percentage of participants	93 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 48; n=51, 53, 54, 44	92 Percentage of participants	92 Percentage of participants	98 Percentage of participants	98 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 60; n=48, 48, 53, 44	94 Percentage of participants	96 Percentage of participants	98 Percentage of participants	95 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 72; n=47, 48, 52, 42	91 Percentage of participants	92 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 84; n=46, 48, 52, 42	91 Percentage of participants	94 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 96; n=45, 48, 52, 40	89 Percentage of participants	98 Percentage of participants	98 Percentage of participants	98 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 108; n=43, 46, 49, 0	95 Percentage of participants	96 Percentage of participants	100 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 120; n=41, 46, 49, 0	95 Percentage of participants	100 Percentage of participants	98 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 132; n=40, 46, 49, 0	95 Percentage of participants	96 Percentage of participants	100 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 144; n=37, 45, 47, 0	92 Percentage of participants	93 Percentage of participants	98 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 156; n=37, 42, 49, 0	95 Percentage of participants	95 Percentage of participants	98 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 168; n=35, 43, 47, 0	94 Percentage of participants	95 Percentage of participants	98 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 180; n=36, 41, 47, 0	97 Percentage of participants	100 Percentage of participants	98 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 192; n=36, 40, 47, 0	94 Percentage of participants	100 Percentage of participants	96 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 204; n=34, 39, 47, 0	97 Percentage of participants	97 Percentage of participants	98 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 216; n=33, 39, 47, 0	100 Percentage of participants	100 Percentage of participants	98 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 228; n=32, 39, 47, 0	100 Percentage of participants	100 Percentage of participants	98 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 240; n=31, 39, 45, 0	97 Percentage of participants	97 Percentage of participants	100 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 252; n=31, 38, 47, 0	100 Percentage of participants	97 Percentage of participants	98 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 264; n=32, 38, 47, 0	100 Percentage of participants	100 Percentage of participants	98 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 276; n=31, 38, 45, 0	100 Percentage of participants	100 Percentage of participants	96 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 288; n=30, 38, 45, 0	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 300; n=31, 37, 44, 0	97 Percentage of participants	100 Percentage of participants	95 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 312; n=31, 33, 43, 0	100 Percentage of participants	97 Percentage of participants	100 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis Week 324; n=3, 4, 3, 0	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Up to Week 324

Population: ITT-E Population

HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease CDC Class A to CDC Class C	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease CDC Class B to CDC Class C	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease CDC Class C to new CDC Class C	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease CDC Class A, B or C to Death	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

Population: ITT-E Population.Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Up to Week 324

Population: On-treatment Phenotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir \[RAL\], Delavirdine \[DLV\], Efavirenz \[EFV\], Etravirine \[ETR\], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine \[ZDV\], Stavudine \[d4T\], Didanosine \[ddI\], Atazanavir/ritonavir \[ATV/r\], Darunavir (DRV)/r, Fosamprenavir/r \[FPV/r\], Indinavir/r \[IDV/r\], Lopinavir/r \[LPV/r\], Nelfinavir \[NFV\], Ritonavir \[RTV\], Saquinavir/r \[SQV/r\], Tipranavir/r \[TPV/r\]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=6 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=2 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=2 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=5 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, TDF; Sensitive; n=6, 2, 2, 5	5 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance INI, GSK1265744; Resistant; n=5, 1, 2, 2	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance INI, GSK1265744; Sensitive; n=5, 1, 2, 2	3 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance INI, RAL; Resistant; n=5, 1, 2, 2	3 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance INI, RAL; Sensitive; n=5, 1, 2, 2	2 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, DLV; Resistant; n=6, 2, 2, 5	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, DLV; Sensitive; n=6, 2, 2, 5	3 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, EFV; Resistant; n=6, 2, 2, 5	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, EFV; Sensitive; n=6, 2, 2, 5	3 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, ETR; Resistant; n=6, 2, 2, 5	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, TDF; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, TDF; Partially sensitive; n=6, 2, 2, 5	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, ZDV; Resistant; n=6, 2, 2, 5	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, ZDV; Sensitive; n=6, 2, 2, 5	4 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, d4T; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, d4T; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, ddI; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, ddI; Partially sensitive; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, ddI; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, ATV/r; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, ATV/r; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, DRV/r; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, DRV/r; Partially sensitive; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, DRV/r; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, FPV/r; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, FPV/r; Partially sensitive; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, FPV/r; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, IDV/r; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, IDV/r; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, LPV/r; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, LPV/r; Partially sensitive; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, LPV/r; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, NFV; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, NFV; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, RTV; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, RPV; Sensitive; n=6, 2, 2, 5	3 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, RTV; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, SQV/r; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, SQV/r; Partially sensitive; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, SQV/r; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, TPV/r; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, TPV/r; Partially sensitive; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance PI, TPV/r; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, ETR; Sensitive; n=6, 2, 2, 5	3 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, 3TC; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, NVP; Resistant; n=6, 2, 2, 5	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, NVP; Sensitive; n=6, 2, 2, 5	3 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NNRTI, RPV; Resistant; n=6, 2, 2, 5	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, 3TC; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, ABC; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, ABC; Partially sensitive; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, ABC; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, FTC; Resistant; n=6, 2, 2, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Phenotypic Resistance NRTI, FTC; Sensitive; n=6, 2, 2, 5	6 Participants	2 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Week 324

Population: On-treatment Genotypic resistance Population

Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=6 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=2 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=2 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=5 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance Any INI mutation	3 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance Any mutation to other classes	4 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312

Population: ITT-E Population. Only participants who were dispensed and returned drug on scheduled visits were included in the analysis (represented by n=X in category titles)

Number of participants with \>=90% adherence to study treatment based on pill count is summarized.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=57 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=55 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=56 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=52 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Adherence to Study Treatment Week 276; n=14, 14, 21, 0	13 Participants	13 Participants	18 Participants	—
Number of Participants With Adherence to Study Treatment Baseline; n=57, 55, 56, 52	53 Participants	51 Participants	55 Participants	48 Participants
Number of Participants With Adherence to Study Treatment Week 4; n=54, 52, 53, 50	46 Participants	49 Participants	52 Participants	44 Participants
Number of Participants With Adherence to Study Treatment Week 8; n=53, 50, 56, 48	49 Participants	45 Participants	53 Participants	47 Participants
Number of Participants With Adherence to Study Treatment Week 12; n=55, 48, 53, 48	44 Participants	40 Participants	46 Participants	43 Participants
Number of Participants With Adherence to Study Treatment Week 16; n=53, 51, 53, 44	44 Participants	45 Participants	50 Participants	42 Participants
Number of Participants With Adherence to Study Treatment Week 20; n=51, 49, 55, 44	45 Participants	40 Participants	51 Participants	41 Participants
Number of Participants With Adherence to Study Treatment Week 24; n=51, 46, 51, 43	47 Participants	41 Participants	48 Participants	39 Participants
Number of Participants With Adherence to Study Treatment Week 28; n=49, 48, 53, 41	45 Participants	46 Participants	48 Participants	35 Participants
Number of Participants With Adherence to Study Treatment Week 32; n=47, 48, 55, 41	46 Participants	42 Participants	52 Participants	37 Participants
Number of Participants With Adherence to Study Treatment Week 36; n=46, 48, 50, 41	40 Participants	43 Participants	48 Participants	36 Participants
Number of Participants With Adherence to Study Treatment Week 40; n=38, 35, 45, 39	33 Participants	30 Participants	41 Participants	34 Participants
Number of Participants With Adherence to Study Treatment Week 48; n=33, 37, 45, 35	32 Participants	33 Participants	41 Participants	33 Participants
Number of Participants With Adherence to Study Treatment Week 60; n=38, 38, 40, 37	37 Participants	35 Participants	37 Participants	35 Participants
Number of Participants With Adherence to Study Treatment Week 72; n=35, 37, 44, 32	32 Participants	35 Participants	41 Participants	27 Participants
Number of Participants With Adherence to Study Treatment Week 84; n=36, 39, 42, 33	34 Participants	36 Participants	39 Participants	29 Participants
Number of Participants With Adherence to Study Treatment Week 96; n=31, 36, 33, 0	25 Participants	32 Participants	30 Participants	—
Number of Participants With Adherence to Study Treatment Week 108; n=23, 23, 29, 0	21 Participants	20 Participants	27 Participants	—
Number of Participants With Adherence to Study Treatment Week 120; n=30, 38, 41, 0	28 Participants	36 Participants	39 Participants	—
Number of Participants With Adherence to Study Treatment Week 132; n=29, 32, 40, 0	28 Participants	30 Participants	35 Participants	—
Number of Participants With Adherence to Study Treatment Week 144; n=33, 34, 43, 0	32 Participants	29 Participants	41 Participants	—
Number of Participants With Adherence to Study Treatment Week 156; n=31, 28, 39, 0	30 Participants	25 Participants	35 Participants	—
Number of Participants With Adherence to Study Treatment Week 168; n=29, 33, 41, 0	29 Participants	24 Participants	35 Participants	—
Number of Participants With Adherence to Study Treatment Week 180; n=26, 29, 39, 0	24 Participants	24 Participants	34 Participants	—
Number of Participants With Adherence to Study Treatment Week 192; n=30, 30, 39, 0	28 Participants	27 Participants	35 Participants	—
Number of Participants With Adherence to Study Treatment Week 204; n=29, 32, 38, 0	27 Participants	26 Participants	33 Participants	—
Number of Participants With Adherence to Study Treatment Week 216; n=29, 30, 37, 0	29 Participants	27 Participants	31 Participants	—
Number of Participants With Adherence to Study Treatment Week 228; n=27, 34, 40, 0	25 Participants	28 Participants	35 Participants	—
Number of Participants With Adherence to Study Treatment Week 240; n=28, 26, 41, 0	28 Participants	22 Participants	35 Participants	—
Number of Participants With Adherence to Study Treatment Week 252; n=23, 26, 33, 0	18 Participants	21 Participants	29 Participants	—
Number of Participants With Adherence to Study Treatment Week 264; n=15, 18, 24, 0	12 Participants	16 Participants	21 Participants	—
Number of Participants With Adherence to Study Treatment Week 288; n=12, 14, 18, 0	12 Participants	10 Participants	17 Participants	—
Number of Participants With Adherence to Study Treatment Week 300; n=12, 13, 20, 0	11 Participants	7 Participants	18 Participants	—
Number of Participants With Adherence to Study Treatment Week 312; n=1, 1, 0, 0	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Week 16 and Week 24

Population: ITT-E Population

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase Week 16	90 Percentage of participants Interval 82.0 to 98.0	83 Percentage of participants Interval 74.0 to 93.0	87 Percentage of participants Interval 78.0 to 95.0	74 Percentage of participants Interval 63.0 to 85.0
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase Week 24	87 Percentage of participants Interval 78.0 to 95.0	85 Percentage of participants Interval 76.0 to 94.0	87 Percentage of participants Interval 78.0 to 95.0	74 Percentage of participants Interval 63.0 to 85.0

SECONDARY outcome

Timeframe: Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

Population: ITT-ME Population

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=52 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=53 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=55 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=47 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 24	96 Percentage of participants	94 Percentage of participants	96 Percentage of participants	96 Percentage of participants
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 26	90 Percentage of participants	85 Percentage of participants	95 Percentage of participants	87 Percentage of participants
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 28	98 Percentage of participants	89 Percentage of participants	95 Percentage of participants	91 Percentage of participants
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 32	96 Percentage of participants	91 Percentage of participants	96 Percentage of participants	91 Percentage of participants
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 36	98 Percentage of participants	92 Percentage of participants	95 Percentage of participants	94 Percentage of participants
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 40	96 Percentage of participants	92 Percentage of participants	95 Percentage of participants	89 Percentage of participants
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 48	92 Percentage of participants	91 Percentage of participants	96 Percentage of participants	94 Percentage of participants
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 60	90 Percentage of participants	83 Percentage of participants	95 Percentage of participants	89 Percentage of participants
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 72	83 Percentage of participants	83 Percentage of participants	95 Percentage of participants	89 Percentage of participants
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 84	83 Percentage of participants	85 Percentage of participants	95 Percentage of participants	89 Percentage of participants
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase Week 96	79 Percentage of participants	85 Percentage of participants	93 Percentage of participants	83 Percentage of participants

SECONDARY outcome

Timeframe: Week 24 to Week 96

Population: Maintenance Safety Population

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=52 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=53 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=55 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=47 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase Any AE	40 Participants	50 Participants	50 Participants	35 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase Any SAE	5 Participants	5 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 24 to Week 96

Population: Maintenance Safety Population

Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=52 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=53 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=55 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=47 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Inorganic phosphorus; Grade 3	2 Participants	1 Participants	5 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase ALT; Grade 1	9 Participants	12 Participants	17 Participants	6 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase ALT; Grade 2	6 Participants	6 Participants	5 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase ALT; Grade 3	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase ALT; Grade 4	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Albumin; Grade 1	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Albumin; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Albumin; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Albumin; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase ALP; Grade 1	2 Participants	1 Participants	4 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase ALP; Grade 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase ALP; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase ALP; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase AST; Grade 1	5 Participants	13 Participants	13 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase AST; Grade 2	5 Participants	8 Participants	5 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase AST; Grade 3	2 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase AST; Grade 4	2 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase CO2/bicarbonate; Grade 1	6 Participants	14 Participants	9 Participants	8 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase CO2/bicarbonate; Grade 2	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase CO2/bicarbonate; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase CO2/bicarbonate; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Cholesterol; Grade 1	17 Participants	17 Participants	19 Participants	9 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Cholesterol; Grade 2	6 Participants	12 Participants	15 Participants	10 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Cholesterol; Grade 3	3 Participants	0 Participants	3 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Cholesterol; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase CK; Grade 1	8 Participants	9 Participants	11 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase CK; Grade 2	2 Participants	4 Participants	4 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase CK; Grade 3	3 Participants	2 Participants	4 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase CK; Grade 4	6 Participants	6 Participants	5 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Creatinine; Grade 1	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Creatinine; Grade 2	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Creatinine; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Creatinine; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Glucose; Grade 1	17 Participants	17 Participants	20 Participants	11 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Glucose; Grade 2	14 Participants	10 Participants	11 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Glucose; Grade 3	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Glucose; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase LDL cholesterol; Grade 1	14 Participants	16 Participants	13 Participants	8 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase LDL cholesterol; Grade 2	6 Participants	11 Participants	14 Participants	6 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase LDL cholesterol; Grade 3	4 Participants	2 Participants	7 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase LDL cholesterol; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Lipase; Grade 1	9 Participants	9 Participants	8 Participants	9 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Lipase; Grade 2	9 Participants	8 Participants	11 Participants	7 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Lipase; Grade 3	5 Participants	1 Participants	6 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Lipase; Grade 4	2 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Inorganic phosphorus; Grade 1	5 Participants	3 Participants	9 Participants	7 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Inorganic phosphorus; Grade 2	10 Participants	11 Participants	5 Participants	9 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Inorganic phosphorus; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Potassium; Grade 1	12 Participants	7 Participants	8 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Potassium; Grade 2	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Potassium; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Potassium; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Sodium; Grade 1	14 Participants	12 Participants	16 Participants	7 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Sodium; Grade 2	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Sodium; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Sodium; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Total bilirubin; Grade 1	7 Participants	1 Participants	8 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Total bilirubin; Grade 2	2 Participants	3 Participants	4 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Total bilirubin; Grade 3	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Total bilirubin; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Triglycerides; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Triglycerides; Grade 2	1 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Triglycerides; Grade 3	1 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase Triglycerides; Grade 4	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24 to Week 96

Population: Maintenance Safety Population

Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=52 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=53 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=55 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=47 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase APTT; Grade 1	5 Participants	5 Participants	5 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase APTT; Grade 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase APTT; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase APTT; Grade 4	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Hemoglobin; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Hemoglobin; Grade 2	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Hemoglobin; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Hemoglobin; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase INR; Grade 1	2 Participants	4 Participants	0 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase INR; Grade 2	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase INR; Grade 3	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase INR; Grade 4	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Platelet count; Grade 1	4 Participants	0 Participants	4 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Platelet count; Grade 2	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Platelet count; Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Platelet count; Grade 4	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase PT; Grade 1	1 Participants	3 Participants	0 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase PT; Grade 2	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase PT; Grade 3	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase PT; Grade 4	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Total neutrophils; Grade 1	7 Participants	9 Participants	10 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Total neutrophils; Grade 2	5 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Total neutrophils; Grade 3	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase Total neutrophils; Grade 4	1 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase WBC count; Grade 1	2 Participants	5 Participants	2 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase WBC count; Grade 2	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase WBC count; Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase WBC count; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 324

Population: Safety Population

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With AEs and SAEs Over Time Any AE	57 Participants	57 Participants	60 Participants	60 Participants
Number of Participants With AEs and SAEs Over Time Any SAE	13 Participants	12 Participants	11 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to Week 324

Population: Safety Population

Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time ALT; Grade 1	9 Participants	12 Participants	19 Participants	8 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time ALT; Grade 2	6 Participants	6 Participants	5 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time ALT; Grade 3	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time ALT; Grade 4	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Albumin; Grade 1	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Albumin; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Albumin; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Albumin; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time ALP; Grade 1	2 Participants	1 Participants	4 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time ALP; Grade 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time ALP; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time ALP; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time AST; Grade 1	7 Participants	13 Participants	15 Participants	7 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time AST; Grade 2	6 Participants	8 Participants	5 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time AST; Grade 3	2 Participants	0 Participants	4 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time AST; Grade 4	2 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time CO2/bicarbonate; Grade 1	6 Participants	14 Participants	9 Participants	8 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time CO2/bicarbonate; Grade 2	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time CO2/bicarbonate; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time CO2/bicarbonate; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Cholesterol; Grade 1	17 Participants	17 Participants	19 Participants	9 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Cholesterol; Grade 2	7 Participants	12 Participants	15 Participants	10 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Cholesterol; Grade 3	3 Participants	0 Participants	3 Participants	6 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Cholesterol; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time CK; Grade 1	9 Participants	10 Participants	12 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time CK; Grade 2	2 Participants	4 Participants	4 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time CK; Grade 3	3 Participants	2 Participants	4 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time CK; Grade 4	7 Participants	6 Participants	5 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Creatinine; Grade 1	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Creatinine; Grade 2	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Creatinine; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Creatinine; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Glucose; Grade 1	19 Participants	18 Participants	21 Participants	12 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Glucose; Grade 2	14 Participants	10 Participants	11 Participants	6 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Glucose; Grade 3	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Glucose; Grade 4	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time LDL cholesterol; Grade 1	14 Participants	17 Participants	13 Participants	8 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time LDL cholesterol; Grade 2	7 Participants	11 Participants	14 Participants	7 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time LDL cholesterol; Grade 3	4 Participants	2 Participants	7 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time LDL cholesterol; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Lipase; Grade 1	11 Participants	9 Participants	9 Participants	10 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Lipase; Grade 2	9 Participants	8 Participants	11 Participants	7 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Lipase; Grade 3	5 Participants	2 Participants	6 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Lipase; Grade 4	2 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Inorganic phosphorus; Grade 1	5 Participants	3 Participants	10 Participants	8 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Inorganic phosphorus; Grade 2	11 Participants	11 Participants	6 Participants	9 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Inorganic phosphorus; Grade 3	2 Participants	1 Participants	5 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Inorganic phosphorus; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Potassium; Grade 1	14 Participants	7 Participants	8 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Potassium; Grade 2	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Potassium; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Potassium; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Sodium; Grade 1	14 Participants	12 Participants	16 Participants	11 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Sodium; Grade 2	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Sodium; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Sodium; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Total bilirubin; Grade 1	7 Participants	1 Participants	8 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Total bilirubin; Grade 2	2 Participants	3 Participants	4 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Total bilirubin; Grade 3	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Total bilirubin; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Triglycerides; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Triglycerides; Grade 2	1 Participants	4 Participants	3 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Triglycerides; Grade 3	1 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time Triglycerides; Grade 4	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 324

Population: Safety Population

Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Platelet count; Grade 4	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time PT; Grade 1	1 Participants	3 Participants	0 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Hemoglobin; Grade 2	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Hemoglobin; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Hemoglobin; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time INR; Grade 1	2 Participants	4 Participants	0 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time INR; Grade 2	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time INR; Grade 3	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time INR; Grade 4	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Platelet count; Grade 1	4 Participants	0 Participants	4 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Platelet count; Grade 2	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Platelet count; Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time APTT; Grade 1	5 Participants	5 Participants	5 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time APTT; Grade 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time APTT; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time APTT; Grade 4	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Hemoglobin; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time PT; Grade 2	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time PT; Grade 3	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time PT; Grade 4	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Total neutrophils; Grade 1	7 Participants	9 Participants	10 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Total neutrophils; Grade 2	5 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Total neutrophils; Grade 3	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time Total neutrophils; Grade 4	1 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time WBC count; Grade 1	2 Participants	5 Participants	2 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time WBC count; Grade 2	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time WBC count; Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time WBC count; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Baseline; n=60, 60, 61, 62	131.0 Milliliters per minute Standard Deviation 28.18	135.2 Milliliters per minute Standard Deviation 41.33	128.3 Milliliters per minute Standard Deviation 33.51	125.6 Milliliters per minute Standard Deviation 35.30
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 2; n=1, 1, 0, 3	96.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	106.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	—	99.0 Milliliters per minute Standard Deviation 31.00
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 4; n=58, 57, 59, 57	129.3 Milliliters per minute Standard Deviation 31.29	132.5 Milliliters per minute Standard Deviation 42.28	122.4 Milliliters per minute Standard Deviation 33.00	127.0 Milliliters per minute Standard Deviation 35.64
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 8; n=2, 1, 1, 1	125.0 Milliliters per minute Standard Deviation 35.36	124.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	143.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	101.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 16; n=55, 53, 56, 49	132.4 Milliliters per minute Standard Deviation 50.97	139.4 Milliliters per minute Standard Deviation 42.30	123.9 Milliliters per minute Standard Deviation 31.85	132.3 Milliliters per minute Standard Deviation 39.97
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 20; n=2, 0, 0, 1	137.0 Milliliters per minute Standard Deviation 11.31	—	—	122.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 24; n=52, 53, 55, 46	127.9 Milliliters per minute Standard Deviation 30.90	132.8 Milliliters per minute Standard Deviation 39.93	120.7 Milliliters per minute Standard Deviation 27.41	135.1 Milliliters per minute Standard Deviation 38.98
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 26; n=0, 1, 0, 0	—	147.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	—	—
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 40; n=0, 1, 0, 0	—	180.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	—	—
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 48; n=51, 50, 54, 44	127.0 Milliliters per minute Standard Deviation 30.01	139.2 Milliliters per minute Standard Deviation 42.07	122.3 Milliliters per minute Standard Deviation 29.21	131.0 Milliliters per minute Standard Deviation 44.41
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 60; n=0, 0, 0, 1	—	—	—	144.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 Week 96; n=45, 48, 52, 40	130.8 Milliliters per minute Standard Deviation 40.80	137.7 Milliliters per minute Standard Deviation 45.07	116.6 Milliliters per minute Standard Deviation 27.05	134.8 Milliliters per minute Standard Deviation 43.35

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Baseline; n=60, 60, 61, 62	141.9 Grams per liter Standard Deviation 12.46	143.2 Grams per liter Standard Deviation 10.66	146.6 Grams per liter Standard Deviation 13.41	145.4 Grams per liter Standard Deviation 12.39
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 2; n=57, 56, 59, 59	142.0 Grams per liter Standard Deviation 13.84	142.8 Grams per liter Standard Deviation 11.68	145.9 Grams per liter Standard Deviation 12.05	146.4 Grams per liter Standard Deviation 13.49
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 4; n=57, 57, 59, 57	141.9 Grams per liter Standard Deviation 13.39	143.5 Grams per liter Standard Deviation 11.69	147.3 Grams per liter Standard Deviation 12.13	146.6 Grams per liter Standard Deviation 13.06
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 8; n=58, 56, 56, 55	144.9 Grams per liter Standard Deviation 13.10	147.7 Grams per liter Standard Deviation 11.88	148.6 Grams per liter Standard Deviation 12.10	148.1 Grams per liter Standard Deviation 12.32
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 12; n=58, 53, 57, 51	144.3 Grams per liter Standard Deviation 12.19	147.4 Grams per liter Standard Deviation 10.60	149.1 Grams per liter Standard Deviation 11.25	149.2 Grams per liter Standard Deviation 13.14
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 16; n=57, 54, 57, 52	143.5 Grams per liter Standard Deviation 11.77	146.5 Grams per liter Standard Deviation 10.71	148.7 Grams per liter Standard Deviation 11.08	147.6 Grams per liter Standard Deviation 12.05
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 20; n=56, 54, 55, 49	144.3 Grams per liter Standard Deviation 13.33	146.9 Grams per liter Standard Deviation 11.23	149.8 Grams per liter Standard Deviation 11.11	147.2 Grams per liter Standard Deviation 12.18
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 24; n=56, 53, 56, 47	144.8 Grams per liter Standard Deviation 12.66	147.8 Grams per liter Standard Deviation 10.69	150.4 Grams per liter Standard Deviation 11.65	148.5 Grams per liter Standard Deviation 11.31
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 26; n=48, 50, 53, 45	144.4 Grams per liter Standard Deviation 13.30	145.8 Grams per liter Standard Deviation 11.63	149.8 Grams per liter Standard Deviation 11.47	148.2 Grams per liter Standard Deviation 12.32
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 28; n=50, 52, 52, 45	143.7 Grams per liter Standard Deviation 13.20	146.8 Grams per liter Standard Deviation 10.89	149.3 Grams per liter Standard Deviation 10.15	145.9 Grams per liter Standard Deviation 13.17
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 32; n=51, 53, 55, 45	144.6 Grams per liter Standard Deviation 9.53	146.1 Grams per liter Standard Deviation 10.44	150.5 Grams per liter Standard Deviation 11.19	145.9 Grams per liter Standard Deviation 11.41
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 36; n=52, 53, 55, 44	142.3 Grams per liter Standard Deviation 11.07	145.9 Grams per liter Standard Deviation 11.24	149.8 Grams per liter Standard Deviation 11.26	145.0 Grams per liter Standard Deviation 10.73
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 40; n=51, 53, 55, 45	142.2 Grams per liter Standard Deviation 11.06	145.2 Grams per liter Standard Deviation 11.03	149.2 Grams per liter Standard Deviation 11.71	145.1 Grams per liter Standard Deviation 9.98
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 48; n=51, 53, 54, 44	142.9 Grams per liter Standard Deviation 9.15	145.7 Grams per liter Standard Deviation 10.59	146.5 Grams per liter Standard Deviation 12.48	145.4 Grams per liter Standard Deviation 12.24
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 60; n=48, 47, 52, 44	144.5 Grams per liter Standard Deviation 9.91	148.3 Grams per liter Standard Deviation 10.96	149.8 Grams per liter Standard Deviation 10.82	147.6 Grams per liter Standard Deviation 12.73
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 72; n=47, 48, 52, 42	143.9 Grams per liter Standard Deviation 10.24	148.1 Grams per liter Standard Deviation 10.15	149.6 Grams per liter Standard Deviation 11.46	147.7 Grams per liter Standard Deviation 11.22
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 84; n=46, 48, 51, 42	145.6 Grams per liter Standard Deviation 11.00	147.7 Grams per liter Standard Deviation 10.04	150.3 Grams per liter Standard Deviation 10.38	147.0 Grams per liter Standard Deviation 11.77
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 Week 96; n=46, 46, 52, 41	144.9 Grams per liter Standard Deviation 12.41	147.1 Grams per liter Standard Deviation 11.06	150.8 Grams per liter Standard Deviation 10.37	147.0 Grams per liter Standard Deviation 11.03

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

Population: Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 2; n=1, 1, 0, 3	-3.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	-10.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	—	-0.7 Milliliters per minute Standard Deviation 0.58
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 4; n=58, 57, 59, 57	-1.4 Milliliters per minute Standard Deviation 12.20	-3.7 Milliliters per minute Standard Deviation 12.18	-4.9 Milliliters per minute Standard Deviation 14.83	-0.1 Milliliters per minute Standard Deviation 10.06
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 8; n=2, 1, 1, 1	5.5 Milliliters per minute Standard Deviation 26.16	-1.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	7.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	0.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 16; n=55, 53, 56, 49	2.2 Milliliters per minute Standard Deviation 37.66	0.2 Milliliters per minute Standard Deviation 15.60	-2.7 Milliliters per minute Standard Deviation 13.89	3.4 Milliliters per minute Standard Deviation 12.94
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 20; n=2, 0, 0, 1	8.0 Milliliters per minute Standard Deviation 7.07	—	—	4.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 24; n=52, 53, 55, 46	-2.7 Milliliters per minute Standard Deviation 22.03	-6.4 Milliliters per minute Standard Deviation 34.13	-5.8 Milliliters per minute Standard Deviation 14.77	4.8 Milliliters per minute Standard Deviation 15.66
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 26; n=0, 1, 0, 0	—	-7.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	—	—
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 40; n=0, 1, 0, 0	—	-95.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	—	—
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 48; n=51, 50, 54, 44	-2.6 Milliliters per minute Standard Deviation 12.72	-1.1 Milliliters per minute Standard Deviation 16.63	-4.5 Milliliters per minute Standard Deviation 14.27	0.4 Milliliters per minute Standard Deviation 19.04
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 60; n=0, 0, 0, 1	—	—	—	16.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 96; n=45, 48, 52, 40	2.2 Milliliters per minute Standard Deviation 31.70	-2.4 Milliliters per minute Standard Deviation 20.43	-9.0 Milliliters per minute Standard Deviation 16.95	5.1 Milliliters per minute Standard Deviation 22.48
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 180; n=1, 0, 0, 0	1.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	—	—	—
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 204; n=0, 1, 0, 0	—	-23.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	—	—
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 252; n=0, 1, 0, 0	—	0.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	—	—
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit Week 264; n=0, 0, 1, 0	—	—	-143.0 Milliliters per minute Standard Deviation NA Standard deviation could not be calculated as only one participant was analyzed at the specified time point	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Change From Baseline in Hemoglobin Level Over Time by Visit Week 2; n=57, 56, 59, 59	0.1 Grams per liter Standard Deviation 6.66	0.0 Grams per liter Standard Deviation 6.25	-0.7 Grams per liter Standard Deviation 6.61	0.7 Grams per liter Standard Deviation 6.90
Change From Baseline in Hemoglobin Level Over Time by Visit Week 4; n=57, 57, 59, 57	-0.2 Grams per liter Standard Deviation 6.41	0.5 Grams per liter Standard Deviation 5.61	0.6 Grams per liter Standard Deviation 7.67	0.7 Grams per liter Standard Deviation 6.40
Change From Baseline in Hemoglobin Level Over Time by Visit Week 8; n=58, 56, 56, 55	2.7 Grams per liter Standard Deviation 9.19	4.8 Grams per liter Standard Deviation 7.23	2.0 Grams per liter Standard Deviation 8.99	2.0 Grams per liter Standard Deviation 9.18
Change From Baseline in Hemoglobin Level Over Time by Visit Week 12; n=58, 53, 57, 51	2.0 Grams per liter Standard Deviation 8.27	3.9 Grams per liter Standard Deviation 7.84	2.6 Grams per liter Standard Deviation 9.59	2.8 Grams per liter Standard Deviation 8.57
Change From Baseline in Hemoglobin Level Over Time by Visit Week 16; n=57, 54, 57, 52	1.1 Grams per liter Standard Deviation 7.58	3.5 Grams per liter Standard Deviation 7.55	2.3 Grams per liter Standard Deviation 9.61	1.1 Grams per liter Standard Deviation 9.22
Change From Baseline in Hemoglobin Level Over Time by Visit Week 20; n=56, 54, 55, 49	2.1 Grams per liter Standard Deviation 8.78	3.8 Grams per liter Standard Deviation 9.28	3.1 Grams per liter Standard Deviation 9.66	0.8 Grams per liter Standard Deviation 9.22
Change From Baseline in Hemoglobin Level Over Time by Visit Week 24; n=56, 53, 56, 47	2.6 Grams per liter Standard Deviation 9.17	4.8 Grams per liter Standard Deviation 7.66	3.6 Grams per liter Standard Deviation 11.04	1.9 Grams per liter Standard Deviation 8.16
Change From Baseline in Hemoglobin Level Over Time by Visit Week 26; n=48, 50, 53, 45	1.8 Grams per liter Standard Deviation 7.68	3.4 Grams per liter Standard Deviation 8.00	2.5 Grams per liter Standard Deviation 9.17	2.2 Grams per liter Standard Deviation 8.11
Change From Baseline in Hemoglobin Level Over Time by Visit Week 28; n=50, 52, 52, 45	1.7 Grams per liter Standard Deviation 8.51	4.0 Grams per liter Standard Deviation 7.93	1.5 Grams per liter Standard Deviation 8.50	0.1 Grams per liter Standard Deviation 10.50
Change From Baseline in Hemoglobin Level Over Time by Visit Week 32; n=51, 53, 55, 45	1.6 Grams per liter Standard Deviation 8.64	3.1 Grams per liter Standard Deviation 8.71	3.5 Grams per liter Standard Deviation 8.49	0.6 Grams per liter Standard Deviation 8.92
Change From Baseline in Hemoglobin Level Over Time by Visit Week 36; n=52, 53, 55, 44	0.3 Grams per liter Standard Deviation 10.21	2.9 Grams per liter Standard Deviation 9.69	2.7 Grams per liter Standard Deviation 11.59	-0.8 Grams per liter Standard Deviation 9.79
Change From Baseline in Hemoglobin Level Over Time by Visit Week 40; n=51, 53, 55, 45	0.5 Grams per liter Standard Deviation 11.44	2.2 Grams per liter Standard Deviation 8.56	2.1 Grams per liter Standard Deviation 9.46	-0.2 Grams per liter Standard Deviation 7.67
Change From Baseline in Hemoglobin Level Over Time by Visit Week 48; n=51, 53, 54, 44	1.2 Grams per liter Standard Deviation 9.84	2.7 Grams per liter Standard Deviation 8.40	-0.5 Grams per liter Standard Deviation 12.03	0.0 Grams per liter Standard Deviation 9.52
Change From Baseline in Hemoglobin Level Over Time by Visit Week 60; n=48, 47, 52, 44	2.6 Grams per liter Standard Deviation 11.23	4.7 Grams per liter Standard Deviation 8.73	2.2 Grams per liter Standard Deviation 11.45	2.3 Grams per liter Standard Deviation 9.18
Change From Baseline in Hemoglobin Level Over Time by Visit Week 72; n=47, 48, 52, 42	1.8 Grams per liter Standard Deviation 11.28	4.5 Grams per liter Standard Deviation 7.39	2.4 Grams per liter Standard Deviation 10.08	2.4 Grams per liter Standard Deviation 9.15
Change From Baseline in Hemoglobin Level Over Time by Visit Week 84; n=46, 48, 51, 42	3.3 Grams per liter Standard Deviation 11.53	4.0 Grams per liter Standard Deviation 8.37	3.0 Grams per liter Standard Deviation 11.34	1.7 Grams per liter Standard Deviation 9.65
Change From Baseline in Hemoglobin Level Over Time by Visit Week 96; n=46, 46, 52, 41	2.7 Grams per liter Standard Deviation 13.41	3.3 Grams per liter Standard Deviation 6.94	3.6 Grams per liter Standard Deviation 10.11	1.9 Grams per liter Standard Deviation 10.06
Change From Baseline in Hemoglobin Level Over Time by Visit Week 108; n=43, 46, 49, 0	4.0 Grams per liter Standard Deviation 11.77	3.4 Grams per liter Standard Deviation 9.42	3.0 Grams per liter Standard Deviation 10.98	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 120; n=41, 46, 49, 0	4.2 Grams per liter Standard Deviation 11.11	4.7 Grams per liter Standard Deviation 8.72	2.1 Grams per liter Standard Deviation 11.39	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 132; n=40, 46, 49, 0	3.5 Grams per liter Standard Deviation 10.89	3.0 Grams per liter Standard Deviation 9.90	2.5 Grams per liter Standard Deviation 12.41	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 144; n=37, 45, 46, 0	4.0 Grams per liter Standard Deviation 12.08	2.6 Grams per liter Standard Deviation 10.64	2.3 Grams per liter Standard Deviation 11.37	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 156; n=37, 42, 49, 0	4.0 Grams per liter Standard Deviation 11.55	5.1 Grams per liter Standard Deviation 9.76	2.7 Grams per liter Standard Deviation 11.88	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 168; n=35, 43, 47, 0	6.3 Grams per liter Standard Deviation 12.60	6.0 Grams per liter Standard Deviation 10.91	4.8 Grams per liter Standard Deviation 10.60	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 180; n=36, 41, 47, 0	5.5 Grams per liter Standard Deviation 11.79	4.0 Grams per liter Standard Deviation 9.23	2.7 Grams per liter Standard Deviation 11.68	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 192; n=35, 40, 47, 0	3.3 Grams per liter Standard Deviation 13.07	3.5 Grams per liter Standard Deviation 9.55	3.0 Grams per liter Standard Deviation 11.51	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 204; n=34, 39, 47, 0	4.5 Grams per liter Standard Deviation 12.73	4.7 Grams per liter Standard Deviation 9.84	3.2 Grams per liter Standard Deviation 11.65	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 216; n=32, 39, 44, 0	4.7 Grams per liter Standard Deviation 14.10	4.1 Grams per liter Standard Deviation 9.97	3.4 Grams per liter Standard Deviation 10.60	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 228; n=31, 39, 47, 0	5.1 Grams per liter Standard Deviation 13.32	4.8 Grams per liter Standard Deviation 10.55	3.1 Grams per liter Standard Deviation 10.53	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 240; n=32, 39, 47, 0	6.2 Grams per liter Standard Deviation 14.38	5.8 Grams per liter Standard Deviation 10.64	2.1 Grams per liter Standard Deviation 11.70	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 252; n=31, 36, 45, 0	6.2 Grams per liter Standard Deviation 14.98	6.4 Grams per liter Standard Deviation 11.76	5.8 Grams per liter Standard Deviation 10.33	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 264; n=32, 38, 46, 0	6.3 Grams per liter Standard Deviation 14.69	6.0 Grams per liter Standard Deviation 9.28	5.5 Grams per liter Standard Deviation 11.07	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 276; n=31, 38, 46, 0	6.6 Grams per liter Standard Deviation 14.67	5.5 Grams per liter Standard Deviation 11.06	5.4 Grams per liter Standard Deviation 10.02	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 288; n=30, 38, 44, 0	7.3 Grams per liter Standard Deviation 12.51	6.8 Grams per liter Standard Deviation 11.38	6.9 Grams per liter Standard Deviation 10.82	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 300; n=30, 37, 43, 0	4.6 Grams per liter Standard Deviation 15.39	5.1 Grams per liter Standard Deviation 10.47	5.5 Grams per liter Standard Deviation 11.56	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 312; n=31, 33, 42, 0	7.0 Grams per liter Standard Deviation 13.56	6.1 Grams per liter Standard Deviation 9.29	8.0 Grams per liter Standard Deviation 10.10	—
Change From Baseline in Hemoglobin Level Over Time by Visit Week 324; n=3, 4, 2, 0	4.3 Grams per liter Standard Deviation 9.07	10.0 Grams per liter Standard Deviation 14.33	20.5 Grams per liter Standard Deviation 7.78	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324

Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Up to Week 324

Population: Safety Population

AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events	7 Percentage of participants	7 Percentage of participants	7 Percentage of participants	15 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 324

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings	25 Participants	19 Participants	15 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety Population

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With AEs and SAEs-Induction Phase Any AE	54 Participants	54 Participants	55 Participants	59 Participants
Number of Participants With AEs and SAEs-Induction Phase Any SAE	2 Participants	0 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety Population

Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase ALT; Grade 1	3 Participants	4 Participants	13 Participants	8 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase ALT; Grade 2	1 Participants	5 Participants	0 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase ALT; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase ALT; Grade 4	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Albumin; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Albumin; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Albumin; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Albumin; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase ALP; Grade 1	0 Participants	1 Participants	4 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase ALP; Grade 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase ALP; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase ALP; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase AST; Grade 1	6 Participants	8 Participants	7 Participants	6 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase AST; Grade 2	2 Participants	5 Participants	1 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase AST; Grade 3	1 Participants	0 Participants	3 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase AST; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase CO2/bicarbonate; Grade 1	1 Participants	5 Participants	1 Participants	6 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase CO2/bicarbonate; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase CO2/bicarbonate; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase CO2/bicarbonate; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Chloride; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Chloride; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Chloride; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Chloride; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Cholesterol; Grade 1	7 Participants	8 Participants	12 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Cholesterol; Grade 2	3 Participants	2 Participants	3 Participants	9 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Cholesterol; Grade 3	0 Participants	0 Participants	2 Participants	6 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Cholesterol; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase CK; Grade 1	7 Participants	5 Participants	6 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase CK; Grade 2	2 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase CK; Grade 3	3 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase CK; Grade 4	2 Participants	4 Participants	2 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Creatinine; Grade 1	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Creatinine; Grade 2	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Creatinine; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Creatinine; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Glucose; Grade 1	10 Participants	8 Participants	13 Participants	6 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Glucose; Grade 2	5 Participants	3 Participants	1 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Glucose; Grade 3	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Glucose; Grade 4	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase HDL cholesterol; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase HDL cholesterol; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase HDL cholesterol; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase HDL cholesterol; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase LDL cholesterol; Grade 1	5 Participants	9 Participants	8 Participants	4 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase LDL cholesterol; Grade 2	4 Participants	1 Participants	5 Participants	8 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase LDL cholesterol; Grade 3	0 Participants	0 Participants	3 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase LDL cholesterol; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Lipase; Grade 1	9 Participants	3 Participants	5 Participants	6 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Lipase; Grade 2	6 Participants	1 Participants	7 Participants	5 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Lipase; Grade 3	2 Participants	1 Participants	4 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Lipase; Grade 4	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Inorganic phosphorus; Grade 1	5 Participants	2 Participants	7 Participants	6 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Inorganic phosphorus; Grade 2	6 Participants	2 Participants	2 Participants	8 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Inorganic phosphorus; Grade 3	1 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Inorganic phosphorus; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Potassium; Grade 1	7 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Potassium; Grade 2	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Potassium; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Potassium; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Sodium; Grade 1	7 Participants	4 Participants	7 Participants	8 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Sodium; Grade 2	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Sodium; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Sodium; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Total bilirubin; Grade 1	0 Participants	1 Participants	4 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Total bilirubin; Grade 2	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Total bilirubin; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Total bilirubin; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Triglycerides; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Triglycerides; Grade 2	0 Participants	1 Participants	3 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Triglycerides; Grade 3	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Triglycerides; Grade 4	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Urea/BUN; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Urea/BUN; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Urea/BUN; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase Urea/BUN; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety Population

Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Lymphocytes; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Lymphocytes; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase MCV; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase MCV; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase MCV; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Monocytes; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase MCV; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Monocytes; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Monocytes; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Monocytes; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Platelet count; Grade 1	2 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Platelet count; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Platelet count; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase PT; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Platelet count; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase WBC count; Grade 1	0 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase WBC count; Grade 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase PT; Grade 4	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase WBC count; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase PT; Grade 1	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase PT; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase RBC; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase WBC count; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase RBC; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Basophils; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase RBC; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Basophils; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase APTT; Grade 1	1 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase APTT; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase RBC; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase APTT; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Eosinophils; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Eosinophils; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase APTT; Grade 4	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Basophils; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Basophils; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Total neutrophils; Grade 1	8 Participants	6 Participants	8 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Total neutrophils; Grade 2	3 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Total neutrophils; Grade 3	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Eosinophils; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Total neutrophils; Grade 4	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Eosinophils; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Hemoglobin; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Hematocrit; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase INR; Grade 1	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase INR; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase INR; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase INR; Grade 4	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Hematocrit; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Hematocrit; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Hematocrit; Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Hemoglobin; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Hemoglobin; Grade 2	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Hemoglobin; Grade 3	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Lymphocytes; Grade 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase Lymphocytes; Grade 2	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: Safety Population

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase	0 Percentage of participants	2 Percentage of participants	5 Percentage of participants	13 Percentage of participants

SECONDARY outcome

Timeframe: Week 24 to Week 96

Population: Maintenance Safety Population

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=52 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=53 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=55 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=47 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase	2 Percentage of participants	4 Percentage of participants	2 Percentage of participants	2 Percentage of participants

SECONDARY outcome

Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2

Population: PK Summary Population

Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=14 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=12 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=11 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2	45.69 Hours*micrograms per milliliter Geometric Coefficient of Variation 32	133.74 Hours*micrograms per milliliter Geometric Coefficient of Variation 32	227.58 Hours*micrograms per milliliter Geometric Coefficient of Variation 57	—

SECONDARY outcome

Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2

Population: PK Summary Population

Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=14 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=12 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=11 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2	2.77 Micrograms per milliliter Geometric Coefficient of Variation 33	7.49 Micrograms per milliliter Geometric Coefficient of Variation 28	13.12 Micrograms per milliliter Geometric Coefficient of Variation 44	—

SECONDARY outcome

Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2

Population: PK Summary Population. Only those participants with data available at the specified time points were analyzed.

Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	GSK1265744 10 mg n=14 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=12 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=9 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2	1.45 Micrograms per milliliter Geometric Coefficient of Variation 37	4.34 Micrograms per milliliter Geometric Coefficient of Variation 38	5.83 Micrograms per milliliter Geometric Coefficient of Variation 61	—

SECONDARY outcome

Timeframe: pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36

Population: PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized

Data was not collected for analysis of rilpivirine PK parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36

Population: PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized

Data was not collected for analysis of rilpivirine PK parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36

Population: PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized

Data was not collected for analysis of rilpivirine PK parameters.

Outcome measures

Outcome data not reported

Adverse Events

GSK1265744 10 mg (Induction Phase)

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

GSK1265744 30 mg (Induction Phase)

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

GSK1265744 60 mg (Induction Phase)

Serious events: 2 serious events

Other events: 50 other events

Deaths: 0 deaths

Efavirenz 600 mg (Induction Phase)

Serious events: 2 serious events

Other events: 54 other events

Deaths: 0 deaths

GSK1265744 10 mg (Maintenance Phase)

Serious events: 5 serious events

Other events: 35 other events

Deaths: 0 deaths

GSK1265744 30 mg (Maintenance Phase)

Serious events: 5 serious events

Other events: 44 other events

Deaths: 0 deaths

GSK1265744 60 mg (Maintenance Phase)

Serious events: 5 serious events

Other events: 47 other events

Deaths: 0 deaths

Efavirenz 600 mg (Maintenance Phase)

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

GSK1265744 10 mg (Open-label Phase)

Serious events: 7 serious events

Other events: 32 other events

Deaths: 0 deaths

GSK1265744 30 mg (Open-label Phase)

Serious events: 8 serious events

Other events: 38 other events

Deaths: 1 deaths

GSK1265744 60 mg (Open-label Phase)

Serious events: 5 serious events

Other events: 40 other events

Deaths: 1 deaths

Efavirenz 600mg (Open-label Phase)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK1265744 10 mg (Induction Phase) n=60 participants at risk Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.	GSK1265744 30 mg (Induction Phase) n=60 participants at risk Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.	GSK1265744 60 mg (Induction Phase) n=61 participants at risk Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.	Efavirenz 600 mg (Induction Phase) n=62 participants at risk Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.	GSK1265744 10 mg (Maintenance Phase) n=52 participants at risk Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.	GSK1265744 30 mg (Maintenance Phase) n=53 participants at risk Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.	GSK1265744 60 mg (Maintenance Phase) n=55 participants at risk Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.	Efavirenz 600 mg (Maintenance Phase) n=47 participants at risk Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily.	GSK1265744 10 mg (Open-label Phase) n=46 participants at risk Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of RPV once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.	GSK1265744 30 mg (Open-label Phase) n=47 participants at risk Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.	GSK1265744 60 mg (Open-label Phase) n=51 participants at risk Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.	Efavirenz 600mg (Open-label Phase) Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Infections and infestations Shigella infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Staphylococcal infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Viral infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Investigations Liver function test increased	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's lymphoma	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Nervous system disorders Headache	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Nervous system disorders Seizure	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Bipolar disorder	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Depression	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Major depression	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Mania	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Suicidal ideation	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Suicide attempt	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Renal and urinary disorders Nephrolithiasis	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Reproductive system and breast disorders Adnexa uteri mass	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Cardiac disorders Atrial flutter	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Cardiac disorders Atrial thrombosis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Cardiac disorders Cardiac arrest	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Cardiac disorders Myocardial infarction	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Anal fistula	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Colitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Enteritis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
General disorders Chest pain	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
General disorders Systemic inflammatory response syndrome	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Abscess	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Abscess intestinal	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Anorectal infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Appendiceal abscess	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Appendicitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Arthritis bacterial	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Cellulitis	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Osteomyelitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Pneumonia	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Pyelonephritis	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Sepsis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.

Other adverse events

Other adverse events
Measure	GSK1265744 10 mg (Induction Phase) n=60 participants at risk Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.	GSK1265744 30 mg (Induction Phase) n=60 participants at risk Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.	GSK1265744 60 mg (Induction Phase) n=61 participants at risk Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.	Efavirenz 600 mg (Induction Phase) n=62 participants at risk Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. All doses were administered orally with meal.	GSK1265744 10 mg (Maintenance Phase) n=52 participants at risk Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.	GSK1265744 30 mg (Maintenance Phase) n=53 participants at risk Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.	GSK1265744 60 mg (Maintenance Phase) n=55 participants at risk Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to 96. All doses were administered orally with meal.	Efavirenz 600 mg (Maintenance Phase) n=47 participants at risk Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily.	GSK1265744 10 mg (Open-label Phase) n=46 participants at risk Participants were administered one tablet of GSK1265744 10 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or 300 mg/200 mg TDF/FTC) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of RPV once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.	GSK1265744 30 mg (Open-label Phase) n=47 participants at risk Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.	GSK1265744 60 mg (Open-label Phase) n=51 participants at risk Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with meal.	Efavirenz 600mg (Open-label Phase) Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Blood and lymphatic system disorders Lymphadenopathy	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.7% 4/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.8% 3/52 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.3% 4/55 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Cardiac disorders Palpitations	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Congenital, familial and genetic disorders Type V hyperlipidaemia	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Endocrine disorders Hypogonadism	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.8% 3/62 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Abdominal pain	8.3% 5/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.7% 4/60 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.6% 4/61 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Anal fissure	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Anal fistula	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Anogenital dysplasia	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Colitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Constipation	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.9% 3/61 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Dental caries	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Diarrhoea	16.7% 10/60 • Number of events 10 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	11.7% 7/60 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	18.0% 11/61 • Number of events 13 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	12.9% 8/62 • Number of events 8 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	9.6% 5/52 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	13.2% 7/53 • Number of events 9 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	9.1% 5/55 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.6% 5/47 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	13.0% 6/46 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.6% 5/47 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	9.8% 5/51 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Dry mouth	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Dyspepsia	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.9% 3/61 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Flatulence	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Food poisoning	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Gastritis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.7% 3/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Haemorrhoids	6.7% 4/60 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.8% 3/62 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.7% 4/46 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Nausea	23.3% 14/60 • Number of events 15 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	18.3% 11/60 • Number of events 14 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	18.0% 11/61 • Number of events 13 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	21.0% 13/62 • Number of events 13 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.7% 3/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	14.5% 8/55 • Number of events 8 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.6% 5/47 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Proctalgia	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Proctitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Toothache	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Gastrointestinal disorders Vomiting	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.7% 4/60 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.9% 3/61 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.8% 3/62 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.5% 4/53 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
General disorders Chest pain	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.6% 4/61 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
General disorders Fatigue	10.0% 6/60 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.3% 5/60 • Number of events 8 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	11.5% 7/61 • Number of events 8 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	16.1% 10/62 • Number of events 10 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.7% 4/52 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	9.4% 5/53 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 3/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.6% 5/47 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
General disorders Feeling drunk	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
General disorders Feeling hot	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
General disorders Influenza like illness	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
General disorders Oedema peripheral	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
General disorders Pain	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 4/62 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
General disorders Pyrexia	1.7% 1/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.9% 3/61 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.8% 3/62 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Immune system disorders Seasonal allergy	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.7% 3/53 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.3% 4/55 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.7% 4/46 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.8% 4/51 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Anal abscess	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Anal chlamydia infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 3/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Body tinea	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Bronchitis	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.3% 5/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.9% 3/61 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.8% 3/62 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.7% 4/52 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.7% 3/53 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.9% 6/55 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.8% 4/51 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Cellulitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Chlamydial infection	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Conjunctivitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Ear infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Eye infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Folliculitis	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Gastroenteritis	8.3% 5/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Gonorrhoea	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.7% 4/52 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.5% 4/53 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.7% 4/46 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.5% 4/47 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Herpes simplex	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Herpes zoster	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Influenza	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Nasopharyngitis	15.0% 9/60 • Number of events 9 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	13.1% 8/61 • Number of events 12 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.8% 3/62 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.5% 4/53 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.6% 5/47 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.9% 5/46 • Number of events 10 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.6% 5/47 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Oral herpes	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Otitis media	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Pharyngitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.7% 4/52 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 3/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Pharyngitis streptococcal	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Pneumonia	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Proctitis gonococcal	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Rhinitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Sinusitis	5.0% 3/60 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.2% 5/61 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	12.8% 6/47 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	11.8% 6/51 • Number of events 10 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Skin infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Syphilis	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.9% 3/61 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	9.6% 5/52 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.5% 4/53 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.7% 4/46 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.8% 4/51 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Tinea cruris	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Tinea infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Tinea pedis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Tooth abscess	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Upper respiratory tract infection	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	13.3% 8/60 • Number of events 8 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	14.8% 9/61 • Number of events 10 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	14.5% 9/62 • Number of events 11 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	17.3% 9/52 • Number of events 11 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	26.4% 14/53 • Number of events 16 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	21.8% 12/55 • Number of events 14 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.6% 5/47 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 3/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	31.9% 15/47 • Number of events 28 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	27.5% 14/51 • Number of events 18 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Urethritis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Urethritis chlamydial	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Urethritis gonococcal	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Urinary tract infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Viral infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Injury, poisoning and procedural complications Contusion	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Injury, poisoning and procedural complications Exposure to communicable disease	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.8% 4/51 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Injury, poisoning and procedural complications Limb injury	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Investigations Blood creatine phosphokinase increased	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Investigations Lipase increased	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Investigations Weight decreased	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Metabolism and nutrition disorders Decreased appetite	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.8% 3/62 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Metabolism and nutrition disorders Hyperlipidaemia	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 1/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.9% 3/61 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.7% 3/53 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 3/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.8% 4/51 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Back pain	8.3% 5/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.7% 4/60 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.8% 3/52 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.3% 4/55 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.5% 4/47 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 3/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	12.8% 6/47 • Number of events 10 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.8% 3/52 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 3/46 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Neck pain	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.0% 3/60 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.8% 4/51 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.3% 4/55 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Nervous system disorders Balance disorder	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Nervous system disorders Disturbance in attention	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 4/62 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Nervous system disorders Dizziness	8.3% 5/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.3% 5/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	29.0% 18/62 • Number of events 19 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Nervous system disorders Headache	21.7% 13/60 • Number of events 14 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	21.7% 13/60 • Number of events 17 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	21.3% 13/61 • Number of events 14 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	11.3% 7/62 • Number of events 8 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.7% 3/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.7% 4/46 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Nervous system disorders Hypoaesthesia	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Nervous system disorders Memory impairment	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Nervous system disorders Paraesthesia	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Nervous system disorders Somnolence	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 4/62 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Abnormal dreams	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.3% 5/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.9% 3/61 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	24.2% 15/62 • Number of events 15 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Anxiety	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 4/62 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	11.8% 6/51 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Anxiety disorder	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Depression	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.3% 5/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	9.6% 5/52 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.3% 4/55 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.5% 4/47 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Insomnia	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.0% 6/60 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	11.5% 7/61 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	22.6% 14/62 • Number of events 15 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.8% 3/52 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.3% 4/55 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.4% 3/47 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.5% 3/46 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.8% 4/51 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Libido decreased	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Psychiatric disorders Major depression	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Renal and urinary disorders Acute kidney injury	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Renal and urinary disorders Dysuria	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Renal and urinary disorders Nocturia	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Renal and urinary disorders Pollakiuria	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Renal and urinary disorders Urinary retention	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Reproductive system and breast disorders Testicular pain	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 5/60 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	8.3% 5/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.6% 4/61 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	9.7% 6/62 • Number of events 6 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.8% 3/52 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.7% 3/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	10.6% 5/47 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.8% 4/51 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/52 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.8% 3/62 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.7% 4/60 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.8% 3/52 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.7% 3/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	12.8% 6/47 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	6.7% 4/60 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Acne	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	6.7% 4/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.9% 3/61 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.5% 3/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/46 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/61 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Eczema	5.0% 3/60 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.8% 2/53 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.9% 2/51 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Night sweats	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.7% 1/60 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.8% 3/62 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/61 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Rash	5.0% 3/60 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.9% 3/61 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	12.9% 8/62 • Number of events 8 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.9% 1/52 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	11.3% 6/53 • Number of events 7 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.6% 2/55 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.9% 3/51 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	3.2% 2/62 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.8% 3/62 • Number of events 5 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.0% 1/51 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.7% 3/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Vascular disorders Hot flush	3.3% 2/60 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.6% 1/62 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/53 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/55 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/46 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/47 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/51 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
Vascular disorders Hypertension	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/60 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/61 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/62 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	0.00% 0/52 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	5.7% 3/53 • Number of events 3 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	1.8% 1/55 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.1% 1/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	2.2% 1/46 • Number of events 1 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	4.3% 2/47 • Number of events 2 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	7.8% 4/51 • Number of events 4 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.	— 0/0 • Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase. Non-SAEs and SAEs were collected in the Safety Population (Induction and Open-label phase) and Maintenance Safety Population (Maintenance Phase). Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 60; n=48, 48, 53, 44	1.648 Log10 copies per milliliter Standard Deviation 0.2643	1.598 Log10 copies per milliliter Standard Deviation 0.0300	1.594 Log10 copies per milliliter Standard Deviation 0.0205	1.657 Log10 copies per milliliter Standard Deviation 0.3948
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 72; n=47, 48, 52, 42	1.625 Log10 copies per milliliter Standard Deviation 0.1584	1.697 Log10 copies per milliliter Standard Deviation 0.4705	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.592 Log10 copies per milliliter Standard Deviation 0.0065
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 84; n=46, 48, 52, 42	1.645 Log10 copies per milliliter Standard Deviation 0.1838	1.643 Log10 copies per milliliter Standard Deviation 0.2896	1.592 Log10 copies per milliliter Standard Deviation 0.0059	1.591 Log10 copies per milliliter Standard Deviation 0.0017
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 96; n=45, 48, 52, 40	1.681 Log10 copies per milliliter Standard Deviation 0.2783	1.603 Log10 copies per milliliter Standard Deviation 0.0861	1.596 Log10 copies per milliliter Standard Deviation 0.0227	1.598 Log10 copies per milliliter Standard Deviation 0.0467
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Baseline; n=60, 60, 61, 62	4.424 Log10 copies per milliliter Standard Deviation 0.5834	4.270 Log10 copies per milliliter Standard Deviation 0.6359	4.428 Log10 copies per milliliter Standard Deviation 0.6418	4.290 Log10 copies per milliliter Standard Deviation 0.6683
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 2; n=57, 56, 59, 59	1.883 Log10 copies per milliliter Standard Deviation 0.4551	1.984 Log10 copies per milliliter Standard Deviation 0.5786	1.939 Log10 copies per milliliter Standard Deviation 0.5071	2.415 Log10 copies per milliliter Standard Deviation 0.5717
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 4; n=58, 57, 59, 57	1.706 Log10 copies per milliliter Standard Deviation 0.3245	1.731 Log10 copies per milliliter Standard Deviation 0.4141	1.725 Log10 copies per milliliter Standard Deviation 0.2750	2.201 Log10 copies per milliliter Standard Deviation 0.5780
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 8; n=59, 56, 57, 55	1.695 Log10 copies per milliliter Standard Deviation 0.4114	1.666 Log10 copies per milliliter Standard Deviation 0.3676	1.666 Log10 copies per milliliter Standard Deviation 0.3926	1.950 Log10 copies per milliliter Standard Deviation 0.5636
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 108; n=43, 46, 49, 0	1.634 Log10 copies per milliliter Standard Deviation 0.1979	1.609 Log10 copies per milliliter Standard Deviation 0.0885	1.591 Log10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 120; n=41, 46, 49, 0	1.638 Log10 copies per milliliter Standard Deviation 0.2216	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.618 Log10 copies per milliliter Standard Deviation 0.1884	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 12; n=58, 52, 57, 51	1.643 Log10 copies per milliliter Standard Deviation 0.2506	1.618 Log10 copies per milliliter Standard Deviation 0.0786	1.641 Log10 copies per milliliter Standard Deviation 0.2033	1.758 Log10 copies per milliliter Standard Deviation 0.4082
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 16; n=57, 54, 57, 52	1.619 Log10 copies per milliliter Standard Deviation 0.1418	1.602 Log10 copies per milliliter Standard Deviation 0.0354	1.616 Log10 copies per milliliter Standard Deviation 0.0956	1.697 Log10 copies per milliliter Standard Deviation 0.3277
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 20; n=56, 54, 56, 47	1.623 Log10 copies per milliliter Standard Deviation 0.1175	1.596 Log10 copies per milliliter Standard Deviation 0.0346	1.599 Log10 copies per milliliter Standard Deviation 0.0591	1.649 Log10 copies per milliliter Standard Deviation 0.1962
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 132; n=40, 46, 49, 0	1.646 Log10 copies per milliliter Standard Deviation 0.2491	1.631 Log10 copies per milliliter Standard Deviation 0.2097	1.591 Log10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 24; n=56, 53, 56, 48	1.615 Log10 copies per milliliter Standard Deviation 0.1010	1.597 Log10 copies per milliliter Standard Deviation 0.0360	1.603 Log10 copies per milliliter Standard Deviation 0.0532	1.610 Log10 copies per milliliter Standard Deviation 0.0902
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 26; n=48, 50, 53, 44	1.595 Log10 copies per milliliter Standard Deviation 0.0270	1.602 Log10 copies per milliliter Standard Deviation 0.0434	1.594 Log10 copies per milliliter Standard Deviation 0.0194	1.610 Log10 copies per milliliter Standard Deviation 0.0742
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 28; n=51, 52, 52, 45	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.607 Log10 copies per milliliter Standard Deviation 0.0565	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.600 Log10 copies per milliliter Standard Deviation 0.0451
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 32; n=52, 53, 55, 45	1.609 Log10 copies per milliliter Standard Deviation 0.0955	1.620 Log10 copies per milliliter Standard Deviation 0.1277	1.618 Log10 copies per milliliter Standard Deviation 0.1742	1.614 Log10 copies per milliliter Standard Deviation 0.1022
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 144; n=37, 45, 47, 0	1.682 Log10 copies per milliliter Standard Deviation 0.4027	1.698 Log10 copies per milliliter Standard Deviation 0.5940	1.630 Log10 copies per milliliter Standard Deviation 0.2656	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 36; n=52, 53, 55, 45	1.604 Log10 copies per milliliter Standard Deviation 0.0782	1.610 Log10 copies per milliliter Standard Deviation 0.1070	1.606 Log10 copies per milliliter Standard Deviation 0.0722	1.607 Log10 copies per milliliter Standard Deviation 0.1068
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 156; n=37, 42, 49, 0	1.634 Log10 copies per milliliter Standard Deviation 0.1850	1.603 Log10 copies per milliliter Standard Deviation 0.0520	1.619 Log10 copies per milliliter Standard Deviation 0.1833	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 40; n=52, 53, 55, 45	1.612 Log10 copies per milliliter Standard Deviation 0.1206	1.618 Log10 copies per milliliter Standard Deviation 0.1214	1.608 Log10 copies per milliliter Standard Deviation 0.0752	1.607 Log10 copies per milliliter Standard Deviation 0.0650
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 48; n=51, 53, 54, 44	1.686 Log10 copies per milliliter Standard Deviation 0.4077	1.654 Log10 copies per milliliter Standard Deviation 0.3673	1.598 Log10 copies per milliliter Standard Deviation 0.0508	1.596 Log10 copies per milliliter Standard Deviation 0.0247
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 168; n=35, 43, 47, 0	1.665 Log10 copies per milliliter Standard Deviation 0.3351	1.642 Log10 copies per milliliter Standard Deviation 0.2908	1.603 Log10 copies per milliliter Standard Deviation 0.0810	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 180; n=36, 41, 47, 0	1.613 Log10 copies per milliliter Standard Deviation 0.1324	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.600 Log10 copies per milliliter Standard Deviation 0.0584	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 192; n=36, 40, 47, 0	1.689 Log10 copies per milliliter Standard Deviation 0.4119	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.699 Log10 copies per milliliter Standard Deviation 0.6971	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 204; n=34, 39, 47, 0	1.628 Log10 copies per milliliter Standard Deviation 0.2162	1.595 Log10 copies per milliliter Standard Deviation 0.0252	1.634 Log10 copies per milliliter Standard Deviation 0.2936	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 216; n=33, 39, 47, 0	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.592 Log10 copies per milliliter Standard Deviation 0.0052	1.634 Log10 copies per milliliter Standard Deviation 0.2948	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 228; n=32, 39, 47, 0	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.625 Log10 copies per milliliter Standard Deviation 0.2351	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 240; n=31, 39, 45, 0	1.596 Log10 copies per milliliter Standard Deviation 0.0268	1.601 Log10 copies per milliliter Standard Deviation 0.0465	1.591 Log10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 252; n=31, 38, 47, 0	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.599 Log10 copies per milliliter Standard Deviation 0.0461	1.593 Log10 copies per milliliter Standard Deviation 0.0157	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 264; n=32, 38, 47, 0	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.617 Log10 copies per milliliter Standard Deviation 0.1788	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 276; n=31, 38, 45, 0	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.618 Log10 copies per milliliter Standard Deviation 0.1398	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 288; n=30, 38, 45, 0	1.591 Log10 copies per milliliter Standard Deviation 0.000	1.592 Log10 copies per milliliter Standard Deviation 0.0052	1.591 Log10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 300; n=31, 37, 44, 0	1.601 Log10 copies per milliliter Standard Deviation 0.0551	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.625 Log10 copies per milliliter Standard Deviation 0.1753	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 312; n=31, 33, 43, 0	1.597 Log10 copies per milliliter Standard Deviation 0.0214	1.600 Log10 copies per milliliter Standard Deviation 0.0494	1.591 Log10 copies per milliliter Standard Deviation 0.0000	—
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit Week 324; n=3, 4, 3, 0	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.591 Log10 copies per milliliter Standard Deviation 0.0000	1.591 Log10 copies per milliliter Standard Deviation 0.0000	—

Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 324; n=3, 4, 3, 0	-2.488 Log10 copies per milliliter Standard Deviation 0.1409	-2.215 Log10 copies per milliliter Standard Deviation 0.4624	-2.438 Log10 copies per milliliter Standard Deviation 0.5904	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 2; n=57, 56, 59, 59	-2.534 Log10 copies per milliliter Standard Deviation 0.4175	-2.306 Log10 copies per milliliter Standard Deviation 0.5937	-2.504 Log10 copies per milliliter Standard Deviation 0.4311	-1.875 Log10 copies per milliliter Standard Deviation 0.4273
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 4; n=58, 57, 59, 57	-2.731 Log10 copies per milliliter Standard Deviation 0.4158	-2.550 Log10 copies per milliliter Standard Deviation 0.6300	-2.718 Log10 copies per milliliter Standard Deviation 0.4981	-2.092 Log10 copies per milliliter Standard Deviation 0.4866
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 8; n=59, 56, 57, 55	-2.733 Log10 copies per milliliter Standard Deviation 0.6374	-2.611 Log10 copies per milliliter Standard Deviation 0.6938	-2.741 Log10 copies per milliliter Standard Deviation 0.7034	-2.344 Log10 copies per milliliter Standard Deviation 0.6765
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 12; n=58, 52, 57, 51	-2.793 Log10 copies per milliliter Standard Deviation 0.5574	-2.634 Log10 copies per milliliter Standard Deviation 0.6308	-2.790 Log10 copies per milliliter Standard Deviation 0.6515	-2.533 Log10 copies per milliliter Standard Deviation 0.6580
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 16; n=57, 54, 57, 52	-2.823 Log10 copies per milliliter Standard Deviation 0.5118	-2.659 Log10 copies per milliliter Standard Deviation 0.6363	-2.815 Log10 copies per milliliter Standard Deviation 0.6170	-2.602 Log10 copies per milliliter Standard Deviation 0.6698
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 20; n=56, 54, 56, 47	-2.823 Log10 copies per milliliter Standard Deviation 0.5329	-2.665 Log10 copies per milliliter Standard Deviation 0.6418	-2.834 Log10 copies per milliliter Standard Deviation 0.6250	-2.666 Log10 copies per milliliter Standard Deviation 0.6512
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 24; n=56, 53, 56, 48	-2.831 Log10 copies per milliliter Standard Deviation 0.5465	-2.659 Log10 copies per milliliter Standard Deviation 0.6488	-2.830 Log10 copies per milliliter Standard Deviation 0.6304	-2.694 Log10 copies per milliliter Standard Deviation 0.6843
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 26; n=48, 50, 53, 44	-2.788 Log10 copies per milliliter Standard Deviation 0.5023	-2.662 Log10 copies per milliliter Standard Deviation 0.6670	-2.792 Log10 copies per milliliter Standard Deviation 0.6014	-2.733 Log10 copies per milliliter Standard Deviation 0.6879
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 28; n=51, 52, 52, 45	-2.784 Log10 copies per milliliter Standard Deviation 0.4944	-2.663 Log10 copies per milliliter Standard Deviation 0.6356	-2.791 Log10 copies per milliliter Standard Deviation 0.5831	-2.714 Log10 copies per milliliter Standard Deviation 0.6873
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 32; n=52, 53, 55, 45	-2.763 Log10 copies per milliliter Standard Deviation 0.5164	-2.636 Log10 copies per milliliter Standard Deviation 0.6598	-2.781 Log10 copies per milliliter Standard Deviation 0.6146	-2.672 Log10 copies per milliliter Standard Deviation 0.6812
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 36; n=52, 53, 55, 45	-2.768 Log10 copies per milliliter Standard Deviation 0.5000	-2.646 Log10 copies per milliliter Standard Deviation 0.6786	-2.792 Log10 copies per milliliter Standard Deviation 0.5803	-2.679 Log10 copies per milliliter Standard Deviation 0.6776
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 40; n=52, 53, 55, 45	-2.760 Log10 copies per milliliter Standard Deviation 0.5143	-2.638 Log10 copies per milliliter Standard Deviation 0.6581	-2.790 Log10 copies per milliliter Standard Deviation 0.5736	-2.679 Log10 copies per milliliter Standard Deviation 0.6817
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 48; n=51, 53, 54, 44	-2.682 Log10 copies per milliliter Standard Deviation 0.6637	-2.602 Log10 copies per milliliter Standard Deviation 0.7855	-2.799 Log10 copies per milliliter Standard Deviation 0.5946	-2.676 Log10 copies per milliliter Standard Deviation 0.6773
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 60; n=48, 48, 53, 44	-2.729 Log10 copies per milliliter Standard Deviation 0.6405	-2.613 Log10 copies per milliliter Standard Deviation 0.6068	-2.787 Log10 copies per milliliter Standard Deviation 0.5920	-2.615 Log10 copies per milliliter Standard Deviation 0.8875
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 72; n=47, 48, 52, 42	-2.745 Log10 copies per milliliter Standard Deviation 0.5229	-2.514 Log10 copies per milliliter Standard Deviation 0.7487	-2.783 Log10 copies per milliliter Standard Deviation 0.6009	-2.738 Log10 copies per milliliter Standard Deviation 0.6415
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 84; n=46, 48, 52, 42	-2.722 Log10 copies per milliliter Standard Deviation 0.5650	-2.568 Log10 copies per milliliter Standard Deviation 0.7144	-2.782 Log10 copies per milliliter Standard Deviation 0.5994	-2.739 Log10 copies per milliliter Standard Deviation 0.6431
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 96; n=45, 48, 52, 40	-2.670 Log10 copies per milliliter Standard Deviation 0.5277	-2.608 Log10 copies per milliliter Standard Deviation 0.6342	-2.778 Log10 copies per milliliter Standard Deviation 0.5943	-2.731 Log10 copies per milliliter Standard Deviation 0.6586
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 108; n=43, 46, 49, 0	-2.723 Log10 copies per milliliter Standard Deviation 0.5396	-2.632 Log10 copies per milliliter Standard Deviation 0.6265	-2.743 Log10 copies per milliliter Standard Deviation 0.5851	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 120; n=41, 46, 49, 0	-2.712 Log10 copies per milliliter Standard Deviation 0.5477	-2.650 Log10 copies per milliliter Standard Deviation 0.6137	-2.717 Log10 copies per milliliter Standard Deviation 0.6180	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 132; n=40, 46, 49, 0	-2.705 Log10 copies per milliliter Standard Deviation 0.5504	-2.610 Log10 copies per milliliter Standard Deviation 0.6718	-2.743 Log10 copies per milliliter Standard Deviation 0.5851	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 144; n=37, 45, 47, 0	-2.690 Log10 copies per milliliter Standard Deviation 0.6615	-2.555 Log10 copies per milliliter Standard Deviation 0.9008	-2.703 Log10 copies per milliliter Standard Deviation 0.6903	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 156; n=37, 42, 49, 0	-2.737 Log10 copies per milliliter Standard Deviation 0.5476	-2.645 Log10 copies per milliliter Standard Deviation 0.6129	-2.716 Log10 copies per milliliter Standard Deviation 0.6309	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 168; n=35, 43, 47, 0	-2.680 Log10 copies per milliliter Standard Deviation 0.6170	-2.592 Log10 copies per milliliter Standard Deviation 0.7138	-2.700 Log10 copies per milliliter Standard Deviation 0.5907	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 180; n=36, 41, 47, 0	-2.747 Log10 copies per milliliter Standard Deviation 0.4984	-2.628 Log10 copies per milliliter Standard Deviation 0.6251	-2.767 Log10 copies per milliliter Standard Deviation 0.5672	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 192; n=36, 40, 47, 0	-2.671 Log10 copies per milliliter Standard Deviation 0.6656	-2.641 Log10 copies per milliliter Standard Deviation 0.6272	-2.667 Log10 copies per milliliter Standard Deviation 0.8708	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 204; n=34, 39, 47, 0	-2.750 Log10 copies per milliliter Standard Deviation 0.5359	-2.632 Log10 copies per milliliter Standard Deviation 0.6353	-2.718 Log10 copies per milliliter Standard Deviation 0.7294	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 216; n=33, 39, 47, 0	-2.787 Log10 copies per milliliter Standard Deviation 0.4956	-2.636 Log10 copies per milliliter Standard Deviation 0.6337	-2.718 Log10 copies per milliliter Standard Deviation 0.6660	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 228; n=32, 39, 47, 0	-2.770 Log10 copies per milliliter Standard Deviation 0.4940	-2.636 Log10 copies per milliliter Standard Deviation 0.6346	-2.726 Log10 copies per milliliter Standard Deviation 0.6757	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 240; n=31, 39, 45, 0	-2.798 Log10 copies per milliliter Standard Deviation 0.4923	-2.627 Log10 copies per milliliter Standard Deviation 0.6181	-2.736 Log10 copies per milliliter Standard Deviation 0.5861	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 252; n=31, 38, 47, 0	-2.787 Log10 copies per milliliter Standard Deviation 0.5092	-2.601 Log10 copies per milliliter Standard Deviation 0.6209	-2.758 Log10 copies per milliliter Standard Deviation 0.5875	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 264; n=32, 38, 47, 0	-2.780 Log10 copies per milliliter Standard Deviation 0.5022	-2.659 Log10 copies per milliliter Standard Deviation 0.6264	-2.734 Log10 copies per milliliter Standard Deviation 0.6213	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 276; n=31, 38, 45, 0	-2.786 Log10 copies per milliliter Standard Deviation 0.5095	-2.659 Log10 copies per milliliter Standard Deviation 0.6264	-2.764 Log10 copies per milliliter Standard Deviation 0.6002	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 288; n=30, 38, 45, 0	-2.768 Log10 copies per milliliter Standard Deviation 0.5083	-2.659 Log10 copies per milliliter Standard Deviation 0.6246	-2.775 Log10 copies per milliliter Standard Deviation 0.5984	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 300; n=31, 37, 44, 0	-2.776 Log10 copies per milliliter Standard Deviation 0.5062	-2.664 Log10 copies per milliliter Standard Deviation 0.6344	-2.730 Log10 copies per milliliter Standard Deviation 0.6786	—
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit Week 312; n=31, 33, 43, 0	-2.780 Log10 copies per milliliter Standard Deviation 0.5085	-2.569 Log10 copies per milliliter Standard Deviation 0.6037	-2.789 Log10 copies per milliliter Standard Deviation 0.5825	—

Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Baseline; n=60, 60, 61, 62	445.5 Cells per cubic millimeter Standard Deviation 155.60	444.9 Cells per cubic millimeter Standard Deviation 190.98	459.0 Cells per cubic millimeter Standard Deviation 170.64	456.5 Cells per cubic millimeter Standard Deviation 196.11
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 2; n=57, 56, 59, 59	544.0 Cells per cubic millimeter Standard Deviation 197.54	525.1 Cells per cubic millimeter Standard Deviation 181.29	549.3 Cells per cubic millimeter Standard Deviation 206.68	487.0 Cells per cubic millimeter Standard Deviation 222.84
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 4; n=58, 57, 59, 57	580.5 Cells per cubic millimeter Standard Deviation 230.40	522.0 Cells per cubic millimeter Standard Deviation 205.80	545.8 Cells per cubic millimeter Standard Deviation 196.79	509.9 Cells per cubic millimeter Standard Deviation 198.21
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 8; n=58, 56, 57, 55	576.6 Cells per cubic millimeter Standard Deviation 196.55	555.2 Cells per cubic millimeter Standard Deviation 210.92	544.3 Cells per cubic millimeter Standard Deviation 176.01	531.4 Cells per cubic millimeter Standard Deviation 175.95
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 12; n=58, 53, 57, 51	588.4 Cells per cubic millimeter Standard Deviation 208.15	599.0 Cells per cubic millimeter Standard Deviation 226.06	596.6 Cells per cubic millimeter Standard Deviation 181.00	564.3 Cells per cubic millimeter Standard Deviation 222.99
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 16; n=57, 54, 57, 52	608.3 Cells per cubic millimeter Standard Deviation 200.34	595.8 Cells per cubic millimeter Standard Deviation 197.47	599.7 Cells per cubic millimeter Standard Deviation 166.77	594.4 Cells per cubic millimeter Standard Deviation 212.63
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 20; n=56, 54, 56, 49	607.3 Cells per cubic millimeter Standard Deviation 204.87	607.4 Cells per cubic millimeter Standard Deviation 199.27	636.6 Cells per cubic millimeter Standard Deviation 225.04	607.7 Cells per cubic millimeter Standard Deviation 186.36
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 24; n=56, 53, 56, 47	614.6 Cells per cubic millimeter Standard Deviation 194.13	626.5 Cells per cubic millimeter Standard Deviation 210.63	658.0 Cells per cubic millimeter Standard Deviation 253.19	599.5 Cells per cubic millimeter Standard Deviation 219.52
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 26; n=48, 50, 53, 45	632.8 Cells per cubic millimeter Standard Deviation 210.93	629.5 Cells per cubic millimeter Standard Deviation 207.34	645.8 Cells per cubic millimeter Standard Deviation 188.61	625.7 Cells per cubic millimeter Standard Deviation 196.46
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 28; n=49, 52, 52, 45	652.2 Cells per cubic millimeter Standard Deviation 225.32	635.9 Cells per cubic millimeter Standard Deviation 217.52	653.3 Cells per cubic millimeter Standard Deviation 261.11	635.7 Cells per cubic millimeter Standard Deviation 224.72
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 32; n=52, 53, 55, 45	638.1 Cells per cubic millimeter Standard Deviation 192.54	650.8 Cells per cubic millimeter Standard Deviation 209.66	665.2 Cells per cubic millimeter Standard Deviation 246.84	663.8 Cells per cubic millimeter Standard Deviation 257.25
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 36; n=52, 53, 55, 45	638.7 Cells per cubic millimeter Standard Deviation 198.05	658.6 Cells per cubic millimeter Standard Deviation 226.51	720.3 Cells per cubic millimeter Standard Deviation 257.85	651.5 Cells per cubic millimeter Standard Deviation 212.15
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 40; n=52, 53, 55, 45	650.2 Cells per cubic millimeter Standard Deviation 218.40	658.5 Cells per cubic millimeter Standard Deviation 204.08	667.6 Cells per cubic millimeter Standard Deviation 187.30	687.9 Cells per cubic millimeter Standard Deviation 241.35
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 48; n=51, 53, 54, 44	677.3 Cells per cubic millimeter Standard Deviation 219.75	687.2 Cells per cubic millimeter Standard Deviation 227.06	713.8 Cells per cubic millimeter Standard Deviation 215.70	732.6 Cells per cubic millimeter Standard Deviation 273.19
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 60; n=48, 47, 53, 44	668.1 Cells per cubic millimeter Standard Deviation 222.61	720.9 Cells per cubic millimeter Standard Deviation 268.74	719.8 Cells per cubic millimeter Standard Deviation 219.04	733.9 Cells per cubic millimeter Standard Deviation 238.90
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 72; n=47, 48, 52, 42	683.2 Cells per cubic millimeter Standard Deviation 242.75	651.3 Cells per cubic millimeter Standard Deviation 217.19	710.9 Cells per cubic millimeter Standard Deviation 259.89	722.5 Cells per cubic millimeter Standard Deviation 263.47
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 84; n=46, 48, 52, 42	718.3 Cells per cubic millimeter Standard Deviation 212.59	736.9 Cells per cubic millimeter Standard Deviation 271.85	735.0 Cells per cubic millimeter Standard Deviation 236.25	744.7 Cells per cubic millimeter Standard Deviation 250.90
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 Week 96; n=46, 46, 52, 41	726.2 Cells per cubic millimeter Standard Deviation 272.28	722.9 Cells per cubic millimeter Standard Deviation 246.22	743.1 Cells per cubic millimeter Standard Deviation 242.23	747.8 Cells per cubic millimeter Standard Deviation 263.27

Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 240; n=32, 39, 47, 0	356.5 Cells per cubic millimeter Standard Deviation 195.99	395.9 Cells per cubic millimeter Standard Deviation 205.55	408.4 Cells per cubic millimeter Standard Deviation 201.05	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 252; n=31, 38, 47, 0	400.3 Cells per cubic millimeter Standard Deviation 183.36	343.7 Cells per cubic millimeter Standard Deviation 196.09	383.1 Cells per cubic millimeter Standard Deviation 217.20	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 264; n=32, 38, 47, 0	344.4 Cells per cubic millimeter Standard Deviation 160.38	365.0 Cells per cubic millimeter Standard Deviation 210.00	391.8 Cells per cubic millimeter Standard Deviation 222.00	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 2; n=57, 56, 59, 59	92.6 Cells per cubic millimeter Standard Deviation 112.44	79.5 Cells per cubic millimeter Standard Deviation 118.15	91.7 Cells per cubic millimeter Standard Deviation 127.92	24.8 Cells per cubic millimeter Standard Deviation 138.47
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 4; n=58, 57, 59, 57	136.4 Cells per cubic millimeter Standard Deviation 157.36	76.9 Cells per cubic millimeter Standard Deviation 107.01	88.2 Cells per cubic millimeter Standard Deviation 110.01	46.0 Cells per cubic millimeter Standard Deviation 106.35
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 8; n=58, 56, 57, 55	129.9 Cells per cubic millimeter Standard Deviation 123.47	117.8 Cells per cubic millimeter Standard Deviation 132.19	90.5 Cells per cubic millimeter Standard Deviation 148.25	65.6 Cells per cubic millimeter Standard Deviation 120.25
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 12; n=58, 53, 57, 51	140.5 Cells per cubic millimeter Standard Deviation 142.86	140.8 Cells per cubic millimeter Standard Deviation 165.02	145.2 Cells per cubic millimeter Standard Deviation 142.24	103.4 Cells per cubic millimeter Standard Deviation 125.39
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 16; n=57, 54, 57, 52	159.3 Cells per cubic millimeter Standard Deviation 115.36	142.2 Cells per cubic millimeter Standard Deviation 145.64	148.3 Cells per cubic millimeter Standard Deviation 131.81	135.5 Cells per cubic millimeter Standard Deviation 153.48
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 20; n=56, 54, 56, 49	165.2 Cells per cubic millimeter Standard Deviation 146.90	153.8 Cells per cubic millimeter Standard Deviation 150.40	182.6 Cells per cubic millimeter Standard Deviation 142.18	149.0 Cells per cubic millimeter Standard Deviation 117.44
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 24; n=56, 53, 56, 47	172.5 Cells per cubic millimeter Standard Deviation 112.04	180.9 Cells per cubic millimeter Standard Deviation 161.43	204.0 Cells per cubic millimeter Standard Deviation 166.78	143.4 Cells per cubic millimeter Standard Deviation 145.18
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 26; n=48, 50, 53, 45	186.4 Cells per cubic millimeter Standard Deviation 153.99	177.7 Cells per cubic millimeter Standard Deviation 146.84	194.7 Cells per cubic millimeter Standard Deviation 149.66	166.4 Cells per cubic millimeter Standard Deviation 145.11
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 28; n=49, 52, 52, 45	205.0 Cells per cubic millimeter Standard Deviation 164.91	188.1 Cells per cubic millimeter Standard Deviation 132.08	193.3 Cells per cubic millimeter Standard Deviation 154.43	178.2 Cells per cubic millimeter Standard Deviation 150.25
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 32; n=52, 53, 55, 45	191.4 Cells per cubic millimeter Standard Deviation 151.79	205.2 Cells per cubic millimeter Standard Deviation 145.53	209.9 Cells per cubic millimeter Standard Deviation 157.56	197.4 Cells per cubic millimeter Standard Deviation 170.48
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 36; n=52, 53, 55, 45	192.0 Cells per cubic millimeter Standard Deviation 165.97	213.0 Cells per cubic millimeter Standard Deviation 144.89	265.0 Cells per cubic millimeter Standard Deviation 169.42	185.2 Cells per cubic millimeter Standard Deviation 152.91
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 40; n=52, 53, 55, 45	203.6 Cells per cubic millimeter Standard Deviation 171.74	212.8 Cells per cubic millimeter Standard Deviation 180.38	212.3 Cells per cubic millimeter Standard Deviation 114.67	221.5 Cells per cubic millimeter Standard Deviation 188.99
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 48; n=51, 53, 54, 44	235.1 Cells per cubic millimeter Standard Deviation 179.89	241.6 Cells per cubic millimeter Standard Deviation 182.90	259.0 Cells per cubic millimeter Standard Deviation 154.21	262.5 Cells per cubic millimeter Standard Deviation 201.33
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 60; n=48, 47, 53, 44	217.7 Cells per cubic millimeter Standard Deviation 152.92	269.4 Cells per cubic millimeter Standard Deviation 188.34	266.1 Cells per cubic millimeter Standard Deviation 156.03	263.8 Cells per cubic millimeter Standard Deviation 181.15
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 72; n=47, 48, 52, 42	232.0 Cells per cubic millimeter Standard Deviation 191.05	201.4 Cells per cubic millimeter Standard Deviation 206.54	254.0 Cells per cubic millimeter Standard Deviation 189.26	257.1 Cells per cubic millimeter Standard Deviation 216.41
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 84; n=46, 48, 52, 42	261.5 Cells per cubic millimeter Standard Deviation 171.65	287.0 Cells per cubic millimeter Standard Deviation 207.10	278.1 Cells per cubic millimeter Standard Deviation 166.11	279.4 Cells per cubic millimeter Standard Deviation 191.30
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 96; n=46, 46, 52, 41	269.4 Cells per cubic millimeter Standard Deviation 204.32	267.5 Cells per cubic millimeter Standard Deviation 196.27	286.2 Cells per cubic millimeter Standard Deviation 181.50	281.7 Cells per cubic millimeter Standard Deviation 232.90
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 108; n=43, 46, 49, 0	296.2 Cells per cubic millimeter Standard Deviation 215.21	304.3 Cells per cubic millimeter Standard Deviation 195.30	288.4 Cells per cubic millimeter Standard Deviation 184.61	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 120; n=41, 46, 49, 0	266.1 Cells per cubic millimeter Standard Deviation 173.09	279.3 Cells per cubic millimeter Standard Deviation 181.10	307.2 Cells per cubic millimeter Standard Deviation 225.39	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 132; n=40, 46, 49, 0	297.1 Cells per cubic millimeter Standard Deviation 167.59	305.2 Cells per cubic millimeter Standard Deviation 184.98	313.2 Cells per cubic millimeter Standard Deviation 168.30	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 144; n=37, 45, 46, 0	330.7 Cells per cubic millimeter Standard Deviation 225.42	308.9 Cells per cubic millimeter Standard Deviation 224.63	322.4 Cells per cubic millimeter Standard Deviation 224.57	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 156; n=37, 42, 49, 0	334.5 Cells per cubic millimeter Standard Deviation 213.79	319.2 Cells per cubic millimeter Standard Deviation 182.15	320.4 Cells per cubic millimeter Standard Deviation 187.58	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 276; n=31, 38, 46, 0	398.3 Cells per cubic millimeter Standard Deviation 250.45	350.3 Cells per cubic millimeter Standard Deviation 210.98	362.2 Cells per cubic millimeter Standard Deviation 243.30	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 168; n=35, 43, 47, 0	338.1 Cells per cubic millimeter Standard Deviation 252.13	332.4 Cells per cubic millimeter Standard Deviation 222.37	361.3 Cells per cubic millimeter Standard Deviation 198.98	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 180; n=36, 41, 47, 0	338.0 Cells per cubic millimeter Standard Deviation 218.72	348.6 Cells per cubic millimeter Standard Deviation 203.73	384.2 Cells per cubic millimeter Standard Deviation 192.86	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 288; n=30, 38, 45, 0	411.0 Cells per cubic millimeter Standard Deviation 161.93	383.5 Cells per cubic millimeter Standard Deviation 279.75	337.1 Cells per cubic millimeter Standard Deviation 187.13	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 192; n=35, 40, 47, 0	300.8 Cells per cubic millimeter Standard Deviation 168.24	351.0 Cells per cubic millimeter Standard Deviation 205.56	342.3 Cells per cubic millimeter Standard Deviation 204.83	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 204; n=34, 39, 47, 0	369.5 Cells per cubic millimeter Standard Deviation 196.17	332.9 Cells per cubic millimeter Standard Deviation 179.28	340.0 Cells per cubic millimeter Standard Deviation 191.82	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 216; n=33, 39, 47, 0	397.0 Cells per cubic millimeter Standard Deviation 202.03	373.4 Cells per cubic millimeter Standard Deviation 188.28	357.8 Cells per cubic millimeter Standard Deviation 199.87	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 228; n=32, 39, 47, 0	331.8 Cells per cubic millimeter Standard Deviation 168.64	366.5 Cells per cubic millimeter Standard Deviation 231.25	383.7 Cells per cubic millimeter Standard Deviation 253.17	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 300; n=30, 37, 44, 0	437.7 Cells per cubic millimeter Standard Deviation 196.33	404.4 Cells per cubic millimeter Standard Deviation 239.11	353.5 Cells per cubic millimeter Standard Deviation 200.23	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 312; n=30, 34, 43, 0	335.0 Cells per cubic millimeter Standard Deviation 176.73	433.0 Cells per cubic millimeter Standard Deviation 264.63	407.0 Cells per cubic millimeter Standard Deviation 178.06	—
Change From Baseline in CD4+ Cell Count Over Time by Visit Week 324; n=3, 4, 3, 0	402.0 Cells per cubic millimeter Standard Deviation 197.55	276.0 Cells per cubic millimeter Standard Deviation 278.28	272.0 Cells per cubic millimeter Standard Deviation 277.44	—

Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 48; n=51, 53, 54, 44	203.5 International Units per Liter Standard Deviation 136.48	219.3 International Units per Liter Standard Deviation 527.75	219.8 International Units per Liter Standard Deviation 195.62	146.3 International Units per Liter Standard Deviation 88.07
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Baseline; n=60, 60, 61, 62	23.9 International Units per Liter Standard Deviation 12.38	28.1 International Units per Liter Standard Deviation 17.65	28.5 International Units per Liter Standard Deviation 20.60	30.5 International Units per Liter Standard Deviation 29.21
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 2; n=58, 56, 58, 58	24.0 International Units per Liter Standard Deviation 13.29	26.3 International Units per Liter Standard Deviation 17.81	27.2 International Units per Liter Standard Deviation 14.49	30.0 International Units per Liter Standard Deviation 26.73
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 4; n=58, 57, 59, 57	23.1 International Units per Liter Standard Deviation 14.31	25.6 International Units per Liter Standard Deviation 17.29	30.3 International Units per Liter Standard Deviation 24.25	31.4 International Units per Liter Standard Deviation 27.43
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 8; n=58, 55, 57, 54	25.4 International Units per Liter Standard Deviation 16.06	29.3 International Units per Liter Standard Deviation 23.15	35.9 International Units per Liter Standard Deviation 63.11	25.0 International Units per Liter Standard Deviation 13.21
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 12; n=58, 53, 57, 51	25.0 International Units per Liter Standard Deviation 15.37	31.4 International Units per Liter Standard Deviation 28.65	26.6 International Units per Liter Standard Deviation 16.27	25.7 International Units per Liter Standard Deviation 17.44
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 16; n=57, 54, 57, 52	26.0 International Units per Liter Standard Deviation 25.88	28.5 International Units per Liter Standard Deviation 27.79	26.9 International Units per Liter Standard Deviation 18.68	30.4 International Units per Liter Standard Deviation 22.55
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 20; n=56, 54, 55, 49	22.3 International Units per Liter Standard Deviation 11.62	24.9 International Units per Liter Standard Deviation 15.72	30.3 International Units per Liter Standard Deviation 24.34	27.0 International Units per Liter Standard Deviation 15.71
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 24; n=56, 53, 56, 47	20.9 International Units per Liter Standard Deviation 9.86	27.5 International Units per Liter Standard Deviation 23.90	28.6 International Units per Liter Standard Deviation 19.62	25.7 International Units per Liter Standard Deviation 13.31
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 26; n=48, 50, 53, 45	24.2 International Units per Liter Standard Deviation 16.54	26.6 International Units per Liter Standard Deviation 26.63	23.5 International Units per Liter Standard Deviation 10.77	28.3 International Units per Liter Standard Deviation 25.23
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 28; n=51, 52, 52, 45	20.4 International Units per Liter Standard Deviation 11.47	26.5 International Units per Liter Standard Deviation 26.66	24.8 International Units per Liter Standard Deviation 14.94	24.2 International Units per Liter Standard Deviation 13.67
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 32; n=52, 53, 55, 45	19.5 International Units per Liter Standard Deviation 9.83	26.9 International Units per Liter Standard Deviation 27.66	23.2 International Units per Liter Standard Deviation 14.67	23.1 International Units per Liter Standard Deviation 10.19
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 36; n=52, 52, 55, 45	23.4 International Units per Liter Standard Deviation 26.79	24.7 International Units per Liter Standard Deviation 17.44	24.2 International Units per Liter Standard Deviation 15.60	23.5 International Units per Liter Standard Deviation 10.53
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 40; n=52, 53, 55, 44	22.7 International Units per Liter Standard Deviation 18.13	24.6 International Units per Liter Standard Deviation 15.43	25.8 International Units per Liter Standard Deviation 23.50	23.4 International Units per Liter Standard Deviation 10.92
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 48; n=51, 53, 54, 44	18.4 International Units per Liter Standard Deviation 8.32	24.8 International Units per Liter Standard Deviation 15.91	24.8 International Units per Liter Standard Deviation 19.60	22.6 International Units per Liter Standard Deviation 10.92
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 60; n=48, 47, 53, 44	21.4 International Units per Liter Standard Deviation 17.70	25.9 International Units per Liter Standard Deviation 16.69	28.1 International Units per Liter Standard Deviation 26.70	24.9 International Units per Liter Standard Deviation 13.59
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 72; n=47, 47, 52, 42	19.9 International Units per Liter Standard Deviation 9.98	30.7 International Units per Liter Standard Deviation 28.68	26.3 International Units per Liter Standard Deviation 20.29	22.7 International Units per Liter Standard Deviation 9.62
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 84; n=46, 48, 52, 42	20.1 International Units per Liter Standard Deviation 11.56	29.9 International Units per Liter Standard Deviation 20.77	25.3 International Units per Liter Standard Deviation 19.53	27.1 International Units per Liter Standard Deviation 32.55
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 ALT; Week 96; n=45, 48, 52, 40	22.0 International Units per Liter Standard Deviation 18.20	48.7 International Units per Liter Standard Deviation 153.96	25.5 International Units per Liter Standard Deviation 21.23	24.3 International Units per Liter Standard Deviation 22.84
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Baseline; n=60, 60, 61, 62	25.0 International Units per Liter Standard Deviation 7.36	27.5 International Units per Liter Standard Deviation 11.15	28.1 International Units per Liter Standard Deviation 12.01	31.5 International Units per Liter Standard Deviation 28.43
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 2; n=58, 56, 58, 58	25.6 International Units per Liter Standard Deviation 8.36	26.6 International Units per Liter Standard Deviation 11.38	26.8 International Units per Liter Standard Deviation 8.60	32.8 International Units per Liter Standard Deviation 51.17
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 4; n=58, 57, 59, 57	24.0 International Units per Liter Standard Deviation 7.95	25.0 International Units per Liter Standard Deviation 11.37	28.3 International Units per Liter Standard Deviation 16.29	29.0 International Units per Liter Standard Deviation 15.61
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 8; n=58, 55, 57, 54	28.7 International Units per Liter Standard Deviation 31.34	29.5 International Units per Liter Standard Deviation 23.47	32.8 International Units per Liter Standard Deviation 37.43	24.4 International Units per Liter Standard Deviation 5.73
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 12; n=58, 53, 57, 51	26.3 International Units per Liter Standard Deviation 13.40	29.0 International Units per Liter Standard Deviation 24.56	25.5 International Units per Liter Standard Deviation 8.05	24.4 International Units per Liter Standard Deviation 9.49
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 16; n=57, 54, 57, 52	24.2 International Units per Liter Standard Deviation 12.70	29.2 International Units per Liter Standard Deviation 24.00	26.5 International Units per Liter Standard Deviation 9.42	36.7 International Units per Liter Standard Deviation 71.83
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 20; n=56, 54, 55, 49	26.0 International Units per Liter Standard Deviation 20.71	24.2 International Units per Liter Standard Deviation 10.38	31.7 International Units per Liter Standard Deviation 26.31	28.7 International Units per Liter Standard Deviation 28.75
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 24; n=56, 53, 56, 47	23.3 International Units per Liter Standard Deviation 8.93	27.2 International Units per Liter Standard Deviation 17.43	28.6 International Units per Liter Standard Deviation 14.12	26.1 International Units per Liter Standard Deviation 9.61
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 26; n=48, 50, 53, 45	28.4 International Units per Liter Standard Deviation 28.28	26.9 International Units per Liter Standard Deviation 18.86	24.5 International Units per Liter Standard Deviation 6.64	25.8 International Units per Liter Standard Deviation 12.21
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 28; n=51, 52, 52, 45	22.6 International Units per Liter Standard Deviation 8.77	26.7 International Units per Liter Standard Deviation 16.58	25.5 International Units per Liter Standard Deviation 11.24	23.7 International Units per Liter Standard Deviation 7.89
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 32; n=52, 53, 55, 45	21.9 International Units per Liter Standard Deviation 7.74	26.5 International Units per Liter Standard Deviation 19.14	25.6 International Units per Liter Standard Deviation 9.19	25.4 International Units per Liter Standard Deviation 12.33
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 36; n=52, 52, 55, 45	29.2 International Units per Liter Standard Deviation 39.15	25.4 International Units per Liter Standard Deviation 12.50	26.4 International Units per Liter Standard Deviation 11.38	26.3 International Units per Liter Standard Deviation 13.66
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 40; n=52, 53, 55, 44	24.7 International Units per Liter Standard Deviation 14.04	24.5 International Units per Liter Standard Deviation 10.35	26.5 International Units per Liter Standard Deviation 14.21	23.0 International Units per Liter Standard Deviation 6.17
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 48; n=51, 53, 54, 44	21.4 International Units per Liter Standard Deviation 8.02	24.3 International Units per Liter Standard Deviation 12.32	24.2 International Units per Liter Standard Deviation 9.26	23.7 International Units per Liter Standard Deviation 8.45
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 60; n=48, 47, 53, 44	23.4 International Units per Liter Standard Deviation 10.41	25.3 International Units per Liter Standard Deviation 12.77	30.4 International Units per Liter Standard Deviation 21.00	24.9 International Units per Liter Standard Deviation 8.31
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 72; n=47, 47, 52, 42	21.8 International Units per Liter Standard Deviation 7.67	31.0 International Units per Liter Standard Deviation 22.80	26.4 International Units per Liter Standard Deviation 10.52	22.9 International Units per Liter Standard Deviation 6.28
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 84; n=46, 48, 52, 42	22.3 International Units per Liter Standard Deviation 8.10	29.2 International Units per Liter Standard Deviation 16.93	25.2 International Units per Liter Standard Deviation 9.11	29.9 International Units per Liter Standard Deviation 37.33
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 AST; Week 96; n=45, 48, 52, 40	23.6 International Units per Liter Standard Deviation 22.38	47.7 International Units per Liter Standard Deviation 150.51	25.9 International Units per Liter Standard Deviation 12.90	27.7 International Units per Liter Standard Deviation 35.71
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Baseline; n=60, 60, 61, 62	197.3 International Units per Liter Standard Deviation 178.83	295.9 International Units per Liter Standard Deviation 604.02	181.2 International Units per Liter Standard Deviation 217.99	349.8 International Units per Liter Standard Deviation 1521.09
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 2; n=58, 56, 58, 58	237.9 International Units per Liter Standard Deviation 271.07	276.1 International Units per Liter Standard Deviation 468.74	184.8 International Units per Liter Standard Deviation 143.83	512.1 International Units per Liter Standard Deviation 2788.37
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 4; n=58, 57, 59, 57	196.7 International Units per Liter Standard Deviation 159.74	221.8 International Units per Liter Standard Deviation 426.95	180.5 International Units per Liter Standard Deviation 174.80	236.2 International Units per Liter Standard Deviation 563.36
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 8; n=58, 55, 57, 54	413.3 International Units per Liter Standard Deviation 1523.18	427.2 International Units per Liter Standard Deviation 1518.27	451.7 International Units per Liter Standard Deviation 1788.60	152.9 International Units per Liter Standard Deviation 94.19
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 12; n=58, 53, 57, 51	316.1 International Units per Liter Standard Deviation 570.21	314.7 International Units per Liter Standard Deviation 1116.09	211.8 International Units per Liter Standard Deviation 174.07	161.2 International Units per Liter Standard Deviation 163.26
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 16; n=57, 54, 57, 52	195.1 International Units per Liter Standard Deviation 180.51	427.3 International Units per Liter Standard Deviation 1339.99	213.3 International Units per Liter Standard Deviation 190.94	646.5 International Units per Liter Standard Deviation 3471.23
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 20; n=56, 54, 55, 49	342.7 International Units per Liter Standard Deviation 953.66	202.1 International Units per Liter Standard Deviation 309.41	485.3 International Units per Liter Standard Deviation 1835.11	528.2 International Units per Liter Standard Deviation 2643.29
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 24; n=56, 53, 56, 47	226.0 International Units per Liter Standard Deviation 230.13	306.3 International Units per Liter Standard Deviation 690.18	243.0 International Units per Liter Standard Deviation 228.95	247.4 International Units per Liter Standard Deviation 498.72
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 26; n=48, 50, 53, 45	344.1 International Units per Liter Standard Deviation 606.10	267.7 International Units per Liter Standard Deviation 516.53	242.5 International Units per Liter Standard Deviation 275.72	163.5 International Units per Liter Standard Deviation 156.79
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 28; n=51, 52, 52, 45	213.4 International Units per Liter Standard Deviation 182.12	276.8 International Units per Liter Standard Deviation 581.44	290.4 International Units per Liter Standard Deviation 457.59	154.7 International Units per Liter Standard Deviation 168.77
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 32; n=52, 53, 55, 45	205.6 International Units per Liter Standard Deviation 171.74	248.8 International Units per Liter Standard Deviation 525.79	311.3 International Units per Liter Standard Deviation 437.31	254.7 International Units per Liter Standard Deviation 778.33
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 36; n=52, 52, 55, 45	528.4 International Units per Liter Standard Deviation 1984.77	242.9 International Units per Liter Standard Deviation 353.65	255.2 International Units per Liter Standard Deviation 275.74	303.1 International Units per Liter Standard Deviation 615.91
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 40; n=52, 53, 55, 44	259.5 International Units per Liter Standard Deviation 381.33	225.4 International Units per Liter Standard Deviation 342.50	292.6 International Units per Liter Standard Deviation 360.32	150.2 International Units per Liter Standard Deviation 96.11
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 60; n=48, 47, 53, 44	315.7 International Units per Liter Standard Deviation 730.27	215.5 International Units per Liter Standard Deviation 340.37	399.6 International Units per Liter Standard Deviation 923.74	168.0 International Units per Liter Standard Deviation 154.36
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 72; n=47, 47, 52, 42	182.5 International Units per Liter Standard Deviation 148.31	354.0 International Units per Liter Standard Deviation 911.76	247.7 International Units per Liter Standard Deviation 348.72	120.5 International Units per Liter Standard Deviation 59.89
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 84; n=46, 48, 52, 42	204.3 International Units per Liter Standard Deviation 160.30	329.2 International Units per Liter Standard Deviation 724.97	195.0 International Units per Liter Standard Deviation 164.14	258.6 International Units per Liter Standard Deviation 650.38
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 CK; Week 96; n=45, 48, 52, 40	542.7 International Units per Liter Standard Deviation 2451.57	272.8 International Units per Liter Standard Deviation 589.15	199.7 International Units per Liter Standard Deviation 194.46	281.1 International Units per Liter Standard Deviation 903.71

Measure	GSK1265744 10 mg n=60 Participants Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 30 mg n=60 Participants Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	GSK1265744 60 mg n=61 Participants Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal.	Efavirenz 600 mg n=62 Participants Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96.
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Baseline; n=60, 60, 61, 62	80.4 Micromoles per liter Standard Deviation 13.69	80.5 Micromoles per liter Standard Deviation 13.55	79.9 Micromoles per liter Standard Deviation 14.11	83.1 Micromoles per liter Standard Deviation 13.41
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 2; n=58, 56, 58, 58	83.8 Micromoles per liter Standard Deviation 14.33	83.3 Micromoles per liter Standard Deviation 14.10	84.6 Micromoles per liter Standard Deviation 15.27	83.8 Micromoles per liter Standard Deviation 15.29
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 4; n=58, 57, 59, 57	82.9 Micromoles per liter Standard Deviation 15.45	83.0 Micromoles per liter Standard Deviation 14.55	84.2 Micromoles per liter Standard Deviation 14.28	83.1 Micromoles per liter Standard Deviation 14.22
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 8; n=58, 55, 57, 54	82.9 Micromoles per liter Standard Deviation 13.79	82.2 Micromoles per liter Standard Deviation 13.03	83.5 Micromoles per liter Standard Deviation 14.41	82.4 Micromoles per liter Standard Deviation 13.94
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 12; n=58, 53, 57, 51	83.8 Micromoles per liter Standard Deviation 13.33	82.7 Micromoles per liter Standard Deviation 14.96	84.1 Micromoles per liter Standard Deviation 14.64	81.1 Micromoles per liter Standard Deviation 12.83
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 16; n=57, 54, 57, 52	83.4 Micromoles per liter Standard Deviation 17.07	82.3 Micromoles per liter Standard Deviation 14.56	82.4 Micromoles per liter Standard Deviation 14.16	79.6 Micromoles per liter Standard Deviation 11.83
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 20; n=56, 54, 55, 49	83.2 Micromoles per liter Standard Deviation 12.95	82.0 Micromoles per liter Standard Deviation 14.42	86.1 Micromoles per liter Standard Deviation 14.34	79.5 Micromoles per liter Standard Deviation 11.72
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 24; n=56, 53, 56, 47	83.2 Micromoles per liter Standard Deviation 13.07	83.3 Micromoles per liter Standard Deviation 15.56	85.2 Micromoles per liter Standard Deviation 13.93	80.0 Micromoles per liter Standard Deviation 20.74
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 26; n=48, 50, 53, 45	83.4 Micromoles per liter Standard Deviation 13.45	82.6 Micromoles per liter Standard Deviation 14.15	87.0 Micromoles per liter Standard Deviation 13.82	78.6 Micromoles per liter Standard Deviation 9.61
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 28; n=51, 52, 52, 45	83.0 Micromoles per liter Standard Deviation 13.32	83.8 Micromoles per liter Standard Deviation 14.84	85.6 Micromoles per liter Standard Deviation 13.96	78.5 Micromoles per liter Standard Deviation 10.34
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 32; n=52, 53, 55, 45	83.8 Micromoles per liter Standard Deviation 14.11	82.6 Micromoles per liter Standard Deviation 13.48	85.7 Micromoles per liter Standard Deviation 14.34	78.1 Micromoles per liter Standard Deviation 9.90
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 36; n=52, 52, 55, 45	83.5 Micromoles per liter Standard Deviation 12.68	84.6 Micromoles per liter Standard Deviation 13.22	86.7 Micromoles per liter Standard Deviation 16.21	78.4 Micromoles per liter Standard Deviation 10.87
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 40; n=52, 53, 55, 44	83.3 Micromoles per liter Standard Deviation 12.60	83.2 Micromoles per liter Standard Deviation 13.04	85.4 Micromoles per liter Standard Deviation 14.38	79.2 Micromoles per liter Standard Deviation 15.99
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 48; n=51, 53, 54, 44	83.4 Micromoles per liter Standard Deviation 13.48	83.1 Micromoles per liter Standard Deviation 14.55	85.0 Micromoles per liter Standard Deviation 14.54	79.0 Micromoles per liter Standard Deviation 12.52
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 60; n=48, 47, 53, 44	83.9 Micromoles per liter Standard Deviation 13.85	83.0 Micromoles per liter Standard Deviation 14.31	85.2 Micromoles per liter Standard Deviation 14.57	77.9 Micromoles per liter Standard Deviation 11.13
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 72; n=47, 47, 52, 42	84.5 Micromoles per liter Standard Deviation 12.46	86.1 Micromoles per liter Standard Deviation 14.95	87.3 Micromoles per liter Standard Deviation 14.95	77.7 Micromoles per liter Standard Deviation 11.44
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 84; n=46, 48, 52, 42	85.0 Micromoles per liter Standard Deviation 15.06	84.8 Micromoles per liter Standard Deviation 17.41	87.3 Micromoles per liter Standard Deviation 13.15	79.7 Micromoles per liter Standard Deviation 11.20
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 Creatinine; Week 96; n=45, 48, 52, 40	82.0 Micromoles per liter Standard Deviation 11.46	86.4 Micromoles per liter Standard Deviation 17.24	88.5 Micromoles per liter Standard Deviation 14.75	81.0 Micromoles per liter Standard Deviation 10.10
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Baseline; n=60, 60, 61, 62	9.2 Micromoles per liter Standard Deviation 4.65	9.4 Micromoles per liter Standard Deviation 4.59	10.5 Micromoles per liter Standard Deviation 5.48	9.7 Micromoles per liter Standard Deviation 4.42
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 2; n=58, 56, 58, 58	9.2 Micromoles per liter Standard Deviation 4.48	9.1 Micromoles per liter Standard Deviation 4.50	10.0 Micromoles per liter Standard Deviation 5.92	6.8 Micromoles per liter Standard Deviation 1.71
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 4; n=58, 57, 59, 57	9.4 Micromoles per liter Standard Deviation 4.40	9.3 Micromoles per liter Standard Deviation 4.47	9.8 Micromoles per liter Standard Deviation 6.05	6.4 Micromoles per liter Standard Deviation 1.61
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 8; n=58, 55, 57, 54	9.3 Micromoles per liter Standard Deviation 4.50	9.0 Micromoles per liter Standard Deviation 3.33	10.1 Micromoles per liter Standard Deviation 5.55	6.3 Micromoles per liter Standard Deviation 1.46
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 12; n=58, 53, 57, 51	9.5 Micromoles per liter Standard Deviation 5.16	8.9 Micromoles per liter Standard Deviation 3.79	10.2 Micromoles per liter Standard Deviation 5.47	7.0 Micromoles per liter Standard Deviation 2.57
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 16; n=57, 54, 57, 52	9.6 Micromoles per liter Standard Deviation 5.04	8.5 Micromoles per liter Standard Deviation 3.90	10.4 Micromoles per liter Standard Deviation 4.88	7.0 Micromoles per liter Standard Deviation 2.61
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 20; n=56, 54, 55, 49	9.0 Micromoles per liter Standard Deviation 4.09	9.0 Micromoles per liter Standard Deviation 4.91	10.4 Micromoles per liter Standard Deviation 5.49	6.8 Micromoles per liter Standard Deviation 1.67
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 24; n=56, 53, 56, 47	9.6 Micromoles per liter Standard Deviation 5.18	9.8 Micromoles per liter Standard Deviation 5.09	10.0 Micromoles per liter Standard Deviation 4.52	6.6 Micromoles per liter Standard Deviation 1.60
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 26; n=48, 50, 53, 45	10.6 Micromoles per liter Standard Deviation 4.97	9.9 Micromoles per liter Standard Deviation 5.83	12.0 Micromoles per liter Standard Deviation 5.11	6.8 Micromoles per liter Standard Deviation 2.19
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 28; n=51, 52, 52, 45	10.3 Micromoles per liter Standard Deviation 4.87	10.2 Micromoles per liter Standard Deviation 5.90	11.4 Micromoles per liter Standard Deviation 4.77	6.4 Micromoles per liter Standard Deviation 1.51
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 32; n=52, 53, 55, 45	9.8 Micromoles per liter Standard Deviation 4.91	9.8 Micromoles per liter Standard Deviation 4.80	11.7 Micromoles per liter Standard Deviation 6.70	6.6 Micromoles per liter Standard Deviation 1.74
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 36; n=52, 52, 55, 45	10.3 Micromoles per liter Standard Deviation 5.25	10.1 Micromoles per liter Standard Deviation 5.47	12.2 Micromoles per liter Standard Deviation 6.08	6.5 Micromoles per liter Standard Deviation 1.71
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 40; n=52, 53, 55, 44	10.8 Micromoles per liter Standard Deviation 5.81	11.2 Micromoles per liter Standard Deviation 7.04	12.3 Micromoles per liter Standard Deviation 6.67	6.3 Micromoles per liter Standard Deviation 1.53
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 48; n=51, 53, 54, 44	10.0 Micromoles per liter Standard Deviation 4.96	9.6 Micromoles per liter Standard Deviation 3.86	10.4 Micromoles per liter Standard Deviation 4.91	6.6 Micromoles per liter Standard Deviation 1.65
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 60; n=48, 47, 53, 44	11.2 Micromoles per liter Standard Deviation 4.28	9.8 Micromoles per liter Standard Deviation 3.75	11.6 Micromoles per liter Standard Deviation 6.28	7.0 Micromoles per liter Standard Deviation 2.13
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 72; n=47, 47, 52, 42	10.8 Micromoles per liter Standard Deviation 6.63	10.0 Micromoles per liter Standard Deviation 4.89	11.4 Micromoles per liter Standard Deviation 5.87	6.5 Micromoles per liter Standard Deviation 1.40
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 84; n=46, 48, 52, 42	11.7 Micromoles per liter Standard Deviation 6.77	9.9 Micromoles per liter Standard Deviation 4.35	12.0 Micromoles per liter Standard Deviation 5.64	6.6 Micromoles per liter Standard Deviation 2.27
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 T. Bilirubin; Week 96; n=45, 48, 52, 40	10.3 Micromoles per liter Standard Deviation 5.29	9.9 Micromoles per liter Standard Deviation 4.58	12.5 Micromoles per liter Standard Deviation 5.61	6.8 Micromoles per liter Standard Deviation 1.80