Trial Outcomes & Findings for Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection (NCT NCT02859961)

Last Updated: 2026-03-04

Results Overview

The proportion of participants experiencing virologic failure was analyzed and reported. Virological failure is defined as two consecutive plasma HIV-1 RNA levels of \>= 200 copies/mL.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

562 participants

Primary outcome timeframe

From T1 (first treatment administration) to week 48 (T48).

Results posted on

2026-03-04

Participant Flow

Study Start Date: 07 DEC 2016 (first subject enrolled)

Participant milestones

Participant milestones
Measure	Part 1 - 350 mg Weekly Injection, Group A 350 mg of PRO 140 (175 mg/mL) SC injection per week. All participants who experienced Virologic Failure (VF) prior to week 48 in Part 1 had the option of entering Part 2 wherein they received higher dose of PRO 140. VF defined as two consecutive HIV-1 RNA levels of \>= 200 copies/mL.	Part 1 - 525 mg Weekly Injection, Group B 525 mg of PRO 140 (175 mg/mL) SC injection per week. All participants who experienced Virologic Failure (VF) prior to week 48 in Part 1 had the option of entering Part 2 wherein they received higher dose of PRO 140. VF defined as two consecutive HIV-1 RNA levels of \>= 200 copies/mL.	Part 1 - 700 mg Weekly Injection, Group C 700 mg of PRO 140 (175 mg/mL) SC injection per week.
Part 1, Main Treatment Phase STARTED	226	205	131
Part 1, Main Treatment Phase COMPLETED	110	70	23
Part 1, Main Treatment Phase NOT COMPLETED	116	135	108
Part 2, Rescue Arm for Group A and B STARTED	69	65	0
Part 2, Rescue Arm for Group A and B COMPLETED	32	30	0
Part 2, Rescue Arm for Group A and B NOT COMPLETED	37	35	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 Participants 350 mg SC injections of PRO 140 (175 mg/mL) per week	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=205 Participants 525 mg SC injections of PRO 140 (175 mg/mL) per week	Part 1 - 700 mg Weekly Injections of PRO 140 Group C n=131 Participants 700 mg SC injections of PRO 140 (175 mg/mL) per week	Total n=562 Participants Total of all reporting groups
Age, Continuous	49.9 years STANDARD_DEVIATION 12.4 • n=41 Participants	48.6 years STANDARD_DEVIATION 12.9 • n=35 Participants	49.8 years STANDARD_DEVIATION 11.6 • n=76 Participants	49.4 years STANDARD_DEVIATION 12.4 • n=565 Participants
Sex: Female, Male Female	42 Participants n=41 Participants	44 Participants n=35 Participants	38 Participants n=76 Participants	124 Participants n=565 Participants
Sex: Female, Male Male	184 Participants n=41 Participants	161 Participants n=35 Participants	93 Participants n=76 Participants	438 Participants n=565 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=41 Participants	2 Participants n=35 Participants	0 Participants n=76 Participants	6 Participants n=565 Participants
Race (NIH/OMB) Asian	4 Participants n=41 Participants	3 Participants n=35 Participants	0 Participants n=76 Participants	7 Participants n=565 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=41 Participants	1 Participants n=35 Participants	0 Participants n=76 Participants	4 Participants n=565 Participants
Race (NIH/OMB) Black or African American	62 Participants n=41 Participants	75 Participants n=35 Participants	53 Participants n=76 Participants	190 Participants n=565 Participants
Race (NIH/OMB) White	149 Participants n=41 Participants	118 Participants n=35 Participants	77 Participants n=76 Participants	344 Participants n=565 Participants
Race (NIH/OMB) More than one race	2 Participants n=41 Participants	2 Participants n=35 Participants	0 Participants n=76 Participants	4 Participants n=565 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=41 Participants	4 Participants n=35 Participants	1 Participants n=76 Participants	7 Participants n=565 Participants
Region of Enrollment United States	226 participants n=41 Participants	205 participants n=35 Participants	131 participants n=76 Participants	562 participants n=565 Participants
Years of HIV Diagnosis	17.8 years STANDARD_DEVIATION 9.44 • n=41 Participants	16.6 years STANDARD_DEVIATION 10.3 • n=35 Participants	16.1 years STANDARD_DEVIATION 9.16 • n=76 Participants	17.1 years STANDARD_DEVIATION 9.69 • n=565 Participants
Mean Treatment Duration	185.5 days STANDARD_DEVIATION 125.8 • n=41 Participants	197.4 days STANDARD_DEVIATION 111.4 • n=35 Participants	159.9 days STANDARD_DEVIATION 101.36 • n=76 Participants	189.9 days STANDARD_DEVIATION 116 • n=565 Participants

PRIMARY outcome

Timeframe: From T1 (first treatment administration) to week 48 (T48).

Population: The primary efficacy analysis population included all patients according to their originally assigned Part 1 treatment arm. Virologic failure was assessed only during Part 1 at the assigned dose. Part 2 (rescue arm) does not represent a separate analytical arm for primary endpoint, as entry into Part 2 required prior virologic failure. Therefore, Part 2 patients remain attributed to their original Part 1 arm for the primary efficacy analysis, and Part 2 is not reported as a standalone arm.

The proportion of participants experiencing virologic failure was analyzed and reported. Virological failure is defined as two consecutive plasma HIV-1 RNA levels of \>= 200 copies/mL.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=205 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=131 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic Failure	0.23 proportion of participants	0.43 proportion of participants	0.45 proportion of participants	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration) to week 48 (T48).

Population: Intent toTreat (ITT) population was defined as the set of subjects who were enrolled or randomized and have at least one dose of leronlimab (PRO 140).

Proportion of participants experiencing virologic failure while on PRO 140 monotherapy arm of the study.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=205 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=131 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Proportion of Participants Experiencing Virologic Failure While on PRO 140 Monotherapy Regimen	0.66 proportion of participants	0.42 proportion of participants	0.41 proportion of participants	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration) to week 48 (T48).

Population: Intent to Treat (ITT) population was defined as the set of subjects who were enrolled or randomized and have at least one dose of leronlimab (PRO 140).

The average time to virologic failure after initiating PRO 140 monotherapy was measured in days for confirmed viral load. For the censored subjects (i.e. subjects who did not have an event) the date of event was the time of the last visit date. Virological failure is defined as two consecutive plasma HIV-1 RNA levels of \>= 200 copies/mL.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=205 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=131 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Time to Virologic Failure After Initiating PRO 140 Monotherapy	136.9 Days Standard Deviation 115.5	197.7 Days Standard Deviation 132.4	200.6 Days Standard Deviation 133.5	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration) to subsequent visit when viral re-suppression achieved (up to 52 weeks).

Population: The analysis population includes all subjects who were enrolled or randomized and have at least one dose of PRO 140 and experienced virologic failure. Per protocol participants in Group C arm (700 mg dose) did not receive rescue therapy after virologic failure, therefore, this group/arm was not assessed for viral suppression after virologic failure.

Virologic suppression was defined as plasma HIV-1 RNA levels \< 50 copies/mL as quantified by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Taqman® Real-Time PCR) assay.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=149 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=86 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Proportion of Participants Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure.	0.92 portion of participants	0.79 portion of participants	—	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration) to subsequent visit when viral re-suppression achieved (up to 52 weeks).

Virologic suppression was defined as plasma HIV-1 RNA levels \< 50 copies/mL as quantified by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Taqman® Real-Time PCR) assay.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=149 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=86 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Time to Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure	78.6 Days Standard Deviation 55.12	60.89 Days Standard Deviation 60.33	—	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration) to week 48 (T48).

Population: Intent toTreat (ITT) population was defined as the set of subjects who were enrolled or randomized and have at least one dose of leronlimab (PRO 140).

Virologic suppression was defined as plasma HIV-1 RNA levels \< 50 copies/mL as quantified by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Taqman® Real-Time PCR) assay.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=205 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=131 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Proportion of Participants With Viral Suppression (HIV-1 RNA < 50 Copies/mL) at Week 48 From the Start of PRO 140 Treatment Phase.	0.33 portion of participants	0.54 portion of participants	0.41 portion of participants	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration) to week 25 (T25).

Population: Treatment adherence in the Safety Population for all three treatment groups. Safety population is defined as all subjects who received at least one dose of PRO 140.

Treatment adherence in the Safety Population for all three treatment groups is provided. Measurement is proportion of subjects that reached treatment week 25 (T25)

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=205 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=131 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Measurement of Treatment Adherence to the PRO 140 Monotherapy Regimen	111 Participants	116 Participants	54 Participants	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration) to last visit, up to 20 months.

Population: The population was defined as the set of subjects who were enrolled or randomized and have at least one dose of leronlimab (PRO 140) and who re-initiated oral combination antiviral therapy.

Total time that participants remain off combination ART regimen will be calculated, defined as the time between start of PRO 140 monotherapy and restart of combination ART Regimen.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=59 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=25 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=8 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Total Time That Participants Remain Off Combination ART Regimen, Defined as the Time Between Start of PRO 140 Monotherapy and Restart of Combination ART Regimen	201.53 days Standard Deviation 131.82	250.48 days Standard Deviation 164.43	273.25 days Standard Deviation 167.63	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration) to week 48 (T48).

Population: The population was defined as the set of subjects who were enrolled or randomized and have at least one dose of leronlimab (PRO 140). Subjects with an undefined change from baseline because of missing data was excluded.

Mean change in CD4 cell count from baseline to final visit for each participant within the Treatment Phase was calculated and summarized. Visit 48 values were imputed using the last observation carried forward if missing.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=204 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=130 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Mean Change in CD4 Cell Count, at Each Visit Within the Treatment Phase	-41.1 cells/uL Standard Deviation 219.3	-7.4 cells/uL Standard Deviation 217.3	7.6 cells/uL Standard Deviation 245.4	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration) to VF visit (up to 7 months).

Population: The population was defined as the set of subjects who were enrolled or randomized and have at least one dose of leronlimab (PRO 140) and had valid phenotypic assay results for maraviroc/PRO140 at both baseline and virologic failure visit. Subjects with missing or invalid values at either timepoint were excluded.

Proportion of participants experiencing emerging resistance exhibited by fold increase (\>= 3-fold increase) in maraviroc and PRO 140 FC (IC90 relative to wild-type virus) between baseline and the time of virologic failure, as a measure of post-baseline phenotypic resistance.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=93 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=38 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=30 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Proportion of Participants Within Each Treatment Group Experiencing Emerging Resistance	0.23 proportion of participants	0.13 proportion of participants	0.13 proportion of participants	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).

Population: The CNS sub-study was analyzed on a small group of selected subjects who were enrolled or randomized and have at least one dose of leronlimab (PRO 140). Subjects with missing or invalid values at either timepoint were excluded. Values below the assay lower limit of detection were imputed as 1 c/mL for calculations.

Central Nervous System (CNS) sub-study Data: mean level of HIV-1 RNA in CSF (cerebrospinal fluid) at T1 (prior to first dose of PRO 140), T4, and VF visits for each treatment group.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=15 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=17 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Mean HIV-1 RNA Concentrations in CSF in Central Nervous System (CNS) Sub-study T4 visit	—	1.90 c/mL Standard Deviation 11.93	1.60 c/mL Standard Deviation 3.57	—	—
Mean HIV-1 RNA Concentrations in CSF in Central Nervous System (CNS) Sub-study VF visit	—	1 c/mL Standard Deviation 0	20.1 c/mL Standard Deviation 17.6	—	—
Mean HIV-1 RNA Concentrations in CSF in Central Nervous System (CNS) Sub-study T1 (prior to first dose) visit	—	1.56 c/mL Standard Deviation 5.60	1.51 c/mL Standard Deviation 4.23	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).

Population: The population was defined as the set of subjects who were enrolled or randomized and have at least one dose of leronlimab (PRO 140). Participants were included in the analysis if they had valid PRO140 concentration data. PRO140 values in plasma below the assay lower limit of detection were imputed as 80 ng/mL for calculations.

PRO 140 concentrations were measured in plasma for a subset of participants at T1, T4, and VF timepoints. Participants contributed data only at timepoints where valid measurements were available. Timepoints with missing or invalid data were excluded.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=5 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=10 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=15 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Mean PRO 140 Concentration in Plasma for Central Nervous System (CNS) Sub-study Visit VF	1536.50 ng/mL Standard Deviation 3501.59	31713.25 ng/mL Standard Deviation 16122.03	16278.38 ng/mL Standard Deviation 24824.48	—	—
Mean PRO 140 Concentration in Plasma for Central Nervous System (CNS) Sub-study Visit T1	80 ng/mL Standard Deviation 0	80 ng/mL Standard Deviation 0	80 ng/mL Standard Deviation 0	—	—
Mean PRO 140 Concentration in Plasma for Central Nervous System (CNS) Sub-study Visit T4	15861.03 ng/mL Standard Deviation 9605.10	21126.59 ng/mL Standard Deviation 8953.93	30672.09 ng/mL Standard Deviation 19165.06	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).

Population: The population was defined as the set of subjects who were enrolled or randomized and have at least one dose of leronlimab (PRO 140). The CNS sub-study was analyzed on a small group of selected subjects. Only participants with available CSF samples were included in the analysis. Therefore, the number of participants analyzed for this outcome is smaller than the overall number enrolled in the main study. Values below the assay lower limit of detection were imputed as 25 ng/mL for calculations.

PRO 140 concentrations were measured in CSF (cerebrospinal fluid) in a subset of participants at visits T1, T4, and VF.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=5 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=10 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=15 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Mean PRO 140 Concentrations in CSF for Central Nervous System (CNS) Sub-study T1 visit	25 ng/mL Standard Deviation 0	25 ng/mL Standard Deviation 0	25 ng/mL Standard Deviation 0	—	—
Mean PRO 140 Concentrations in CSF for Central Nervous System (CNS) Sub-study T4 visit	30.87 ng/mL Standard Deviation 16.44	40.84 ng/mL Standard Deviation 677.89	63.78 ng/mL Standard Deviation 78.47	—	—
Mean PRO 140 Concentrations in CSF for Central Nervous System (CNS) Sub-study VF visit	—	47.91 ng/mL Standard Deviation 47.23	94.27 ng/mL Standard Deviation 269.45	—	—

SECONDARY outcome

Timeframe: From T1 (first treatment administration), T4 visit (week 4), and T16 visit (up to 16 weeks).

Population: The GU sub-study was analyzed on a small group of selected subjects. Values below the assay lower limit of detection were imputed as 1 c/mL. Samples that did not have sufficient sample volume for analysis or target was not detected were excluded from the calculations.

Level of HIV-1 RNA in genital secretion at T1 (prior to first dose of PRO 140), T4, and T16 visits.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=1 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=4 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=1 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Mean HIV-1 RNA Concentrations in Genital Secretion in Genitourinary (GU) Sub-study T1 visit	—	1 c/mL Standard Deviation 0	1 c/mL Standard Deviation 0	—	—
Mean HIV-1 RNA Concentrations in Genital Secretion in Genitourinary (GU) Sub-study T4 visit	—	1 c/mL Standard Deviation 0	1 c/mL Standard Deviation 0	—	—
Mean HIV-1 RNA Concentrations in Genital Secretion in Genitourinary (GU) Sub-study T16 visit	258 c/mL Standard Deviation 0	38.83 c/mL Standard Deviation 1065.61	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From T1 (first treatment administration) to week 48 (T48)

Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale). Subjects were asked to mark the point that best represents the average pain intensity at the injection site on a horizontal line (100 mm in length) anchored by the following word descriptors at each end, "no pain" on the left side and "pain as bad as it could possibly be" on the right side of the line. The VAS score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks. Possible scores range from 0 to 100, with higher scores indicating greater pain.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=223 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=197 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=128 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Tolerability of Repeated Subcutaneous Administration of PRO 140 Left Side	0.84 score on a scale Standard Deviation 1.30	0.91 score on a scale Standard Deviation 2.82	1.08 score on a scale Standard Deviation 1.70	—	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 Right Side	0.87 score on a scale Standard Deviation 1.33	0.90 score on a scale Standard Deviation 1.41	0.98 score on a scale Standard Deviation 1.94	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From T1 (first treatment administration) to week 48 (T48).

Population: The Safety population was defined as all subjects who received at least one dose of leronlimab (PRO 140). This population was used for the analysis of safety parameters. For safety analyses, Grade 3 and 4 AEs were summarized by treatment periods (Part 1 and 2) according to treatment received. Participants who entered Part 2 are included in both their original Part 1 and Part 2 safety populations. Therefore, the total across safety groups exceeds the number of unique participants enrolled.

Adverse Events (AEs) are presented based on severity, per Investigator discretion. Severity grades were based on the Division of Aids (DAIDS) grading guidelines. For safety analyses, Grade 3 and 4 AEs were summarized separately for treatment periods corresponding to Part 1 and Part 2 due to differences in dosing and treatment exposure. Participants who entered Part 2 (rescue treatment) received an increased dose of leronlimab and therefore constitute a distinct safety population. For this reason, AEs occurring during Part 2 are represented separately from Part 1, although Part 2 does not represent a separate study arm for efficacy analyses and participants remain attributed to their original Part 1 treatment arm in the overall study design.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=205 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=131 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A n=69 Participants Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B n=65 Participants Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Frequency of Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale	18 Participants	8 Participants	8 Participants	4 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From T1 (first treatment administration) to week 48 (T48).

Population: The Safety population was defined as all subjects who received at least one dose of leronlimab (PRO 140). This population was used for the analysis of safety parameters. For safety analyses, SAEs were summarized by treatment periods (Part 1 and 2) according to treatment received. Participants who entered Part 2 (rescue treatment) are included in both their original Part 1 and Part 2 safety populations. Therefore, the total across safety groups exceeds the number of unique participants enrolled.

Serious adverse events (SAEs) that occurred during the study include all adverse events that occurred from when the subject signed the informed consent form. For safety analyses, SAEs were summarized separately for treatment periods corresponding to Part 1 and Part 2 due to differences in dosing and treatment exposure. Participants who entered Part 2 (rescue treatment) received an increased dose of leronlimab and therefore constitute a distinct safety population. For this reason, SAEs occurring during Part 2 are represented separately from Part 1, although Part 2 does not represent a separate study arm for efficacy analyses and participants remain attributed to their original Part 1 treatment arm in the overall study design.

Outcome measures

Outcome measures
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 Participants Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=205 Participants Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=131 Participants Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A n=69 Participants Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B n=65 Participants Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Frequency of Treatment-Emergent Serious Adverse Events	16 Participants	12 Participants	7 Participants	4 Participants	3 Participants

Adverse Events

Part 1 - 350 mg Weekly Injections of PRO 140, Group A

Serious events: 16 serious events

Other events: 119 other events

Deaths: 1 deaths

Part 1 - 525 mg Weekly Injections of PRO 140, Group B

Serious events: 12 serious events

Other events: 41 other events

Deaths: 1 deaths

Part 1 - 700 mg Weekly Injections of PRO 140, Group C

Serious events: 7 serious events

Other events: 28 other events

Deaths: 1 deaths

Part 2 - Group A

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

Part 2 - Group B

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 participants at risk Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=205 participants at risk Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=131 participants at risk Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A n=69 participants at risk Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B n=65 participants at risk Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
Cardiac disorders Coronary Artery Disease	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.4% 1/69 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Gastrointestinal disorders Abdominal Pain Upper	0.88% 2/226 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Gastrointestinal disorders Intestinal obstruction	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Gastrointestinal disorders Pancreatitis acute	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Gastrointestinal disorders Small intestinal obstruction	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Appendicitis	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Gastroenteritis shigella	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Klebsiella sepsis	0.44% 1/226 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Localised infection	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.4% 1/69 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Meningitis aseptic	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.4% 1/69 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Meningitis bacterial	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Injury, poisoning and procedural complications Craniocerebral injury	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Metabolism and nutrition disorders Dehydration	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 1/65 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Nervous system disorders Alcoholic seizure	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Nervous system disorders Seizures	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 1/65 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Nervous system disorders Subarachnoid haemorrhage	0.44% 1/226 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Psychiatric disorders Hallucination	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
General disorders Multiple organ failure	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Surgical and medical procedures Cholecystectomy	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Gastrointestinal disorders Gastroenteritis	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.98% 2/205 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Bacteremia	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 1/65 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Herpes Zoster	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Pneumonia	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.4% 1/69 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 1/65 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Septic shock	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Meningitis Cryptococcal	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Cellulitis	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.4% 1/69 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Psychiatric disorders Acute Psychosis	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Respiratory, thoracic and mediastinal disorders chronic obstructive pulmonary disease	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Injury, poisoning and procedural complications Traumatic haemorrhage	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
General disorders Chest pain	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Gastrointestinal disorders Anal fistula	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/131 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Psychiatric disorders Acute mental status change	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Nervous system disorders Dizziness	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Nervous system disorders Cerebrovascular accident	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 2/131 • Number of events 3 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/226 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.

Other adverse events

Other adverse events
Measure	Part 1 - 350 mg Weekly Injections of PRO 140, Group A n=226 participants at risk Part 1 - Group A participants received 350 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group A (Rescue Arm) and receiving 525 or 700 mg PRO 140.	Part 1 - 525 mg Weekly Injections of PRO 140, Group B n=205 participants at risk Part 1 - Group B participants received 525 mg of PRO 140 SC injections per week. Participants who experienced virologic failure had an option of entering Part 2 - Group B (Rescue Arm) and receiving 700 mg PRO 140.	Part 1 - 700 mg Weekly Injections of PRO 140, Group C n=131 participants at risk Part 1 Group C participants received 700 mg of PRO 140 SC injections per week.	Part 2 - Group A n=69 participants at risk Part 2 - Group A is a rescue arm for Part 1 Group A patients who had virologic failure. Patients elected to receive 525 or 700 mg PRO 140 SC after experiencing virologic failure on 350 mg SC weekly dose.	Part 2 - Group B n=65 participants at risk Part 2 - Group B is a rescue arm for Part 1 Group B patients who had virologic failure. Patients elected to receive 700 mg PRO 140 SC after experiencing virologic failure on 525 mg SC weekly dose.
General disorders Injection site haemorrhage	8.0% 18/226 • Number of events 38 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	2.9% 6/205 • Number of events 11 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	7.2% 5/69 • Number of events 10 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 1/65 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Musculoskeletal and connective tissue disorders Back pain	5.8% 13/226 • Number of events 13 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.98% 2/205 • Number of events 3 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	2.3% 3/131 • Number of events 3 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	7.2% 5/69 • Number of events 5 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	3.1% 2/65 • Number of events 3 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Gastrointestinal disorders Diarrhoea	8.8% 20/226 • Number of events 23 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	4.4% 9/205 • Number of events 11 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	3.8% 5/131 • Number of events 7 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	8.7% 6/69 • Number of events 7 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	9.2% 6/65 • Number of events 6 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Nervous system disorders Headache	8.0% 18/226 • Number of events 22 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	4.4% 9/205 • Number of events 11 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	4.6% 6/131 • Number of events 7 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	7.2% 5/69 • Number of events 6 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	7.7% 5/65 • Number of events 5 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Nasopharyngitis	4.0% 9/226 • Number of events 9 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	2.9% 6/205 • Number of events 6 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	7.2% 5/69 • Number of events 6 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 1/65 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Gastrointestinal disorders Nausea	7.1% 16/226 • Number of events 19 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	3.4% 7/205 • Number of events 11 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 2/131 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	5.8% 4/69 • Number of events 7 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	7.7% 5/65 • Number of events 5 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Nervous system disorders Presyncope	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/205 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	5.8% 4/69 • Number of events 4 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Upper respiratory tract infection	8.8% 20/226 • Number of events 24 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	6.8% 14/205 • Number of events 19 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	6.9% 9/131 • Number of events 13 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	17.4% 12/69 • Number of events 17 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	18.5% 12/65 • Number of events 14 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Gastrointestinal disorders Vomiting	4.0% 9/226 • Number of events 9 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	2.0% 4/205 • Number of events 4 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	5.8% 4/69 • Number of events 6 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	6.2% 4/65 • Number of events 4 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Infections and infestations Viral upper respiratory tract infection	2.7% 6/226 • Number of events 8 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	3.9% 8/205 • Number of events 9 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	3.1% 4/131 • Number of events 5 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	14.5% 10/69 • Number of events 16 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	6.2% 4/65 • Number of events 5 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Gastrointestinal disorders Abdominal pain	5.3% 12/226 • Number of events 13 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	2.9% 6/205 • Number of events 9 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 2/131 • Number of events 3 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	2.9% 2/69 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	4.6% 3/65 • Number of events 3 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
General disorders Fatigue	8.4% 19/226 • Number of events 21 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	2.9% 6/205 • Number of events 11 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	3.8% 5/131 • Number of events 5 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	4.3% 3/69 • Number of events 3 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	4.6% 3/65 • Number of events 3 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
General disorders Injection site pain	6.2% 14/226 • Number of events 28 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	2.9% 6/205 • Number of events 8 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	2.9% 2/69 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/65 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
General disorders Injection site pruritus	5.8% 13/226 • Number of events 16 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 3/205 • Number of events 8 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 2/131 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	4.6% 3/65 • Number of events 3 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
Psychiatric disorders Drug abuse	0.44% 1/226 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.49% 1/205 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.76% 1/131 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	0.00% 0/69 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	6.2% 4/65 • Number of events 4 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.
General disorders Injection site erythema	4.4% 10/226 • Number of events 11 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	3.4% 7/205 • Number of events 20 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.5% 2/131 • Number of events 2 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	1.4% 1/69 • Number of events 1 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.	6.2% 4/65 • Number of events 6 • Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months. Participants who experienced virologic failure on 350 mg or 525 mg had an option of entering Part 2 (Rescue Arm). 69 participants enrolled from Part1 - Group A into Part 2 - Group A. 65 participants enrolled from Part 1 - Group B into Part 2 - Group B. For the purposes of adverse event reporting, participants who entered the Rescue Arm were analyzed separately. AE data collected after rescue treatment initiation are presented only for the Rescue Arm and excluded from the initial assigned arm.

Additional Information

Vice President, Clinical Operations

CytoDyn

Phone: (360) 980-8524

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60