Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years (NCT NCT00799864)

Last Updated: 2024-06-25

Results Overview

AUC24,ss was defined as the area under the plasma concentration versus time curve from time 0 to 24 hours post dosing of rilpivirine at steady state (steady state starting from Day 14). In the below data table, the measure type "Number" corresponds to AUC24, ss concentration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18)

Results posted on

2024-06-25

Participant Flow

A total of 54 antiretroviral-naïve human Immunodeficiency Virus-1 (HIV-1) infected adolescents (aged greater than or equal to \[\>=\] 12 to less than \[\<\] 18 years) and children (aged \>=6 to \<12 years) were enrolled and treated in Cohort 1 and Cohort 2, respectively.

As of Protocol Amendment 10 (PA 10), for Cohort 2 children \>=6 to \<12 years of age, post Week 48 treatment extension period of 4 years was removed. Hence, the planned efficacy analysis were performed till Week 48 only whereas safety analysis was performed and reported up to Week 240.

Participant milestones

Participant milestones
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Overall Study STARTED	36	9	5	2	2
Overall Study COMPLETED	25	6	3	2	2
Overall Study NOT COMPLETED	11	3	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Overall Study Participant reached a virologic endpoint	9	2	2	0	0
Overall Study Other	2	1	0	0	0

Baseline Characteristics

A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=36 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=9 Participants Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg n=5 Participants Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg n=2 Participants Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg n=2 Participants Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Total n=54 Participants Total of all reporting groups
Age, Continuous	14.6 years STANDARD_DEVIATION 1.66 • n=5 Participants	9.4 years STANDARD_DEVIATION 1.67 • n=7 Participants	9.2 years STANDARD_DEVIATION 0.84 • n=5 Participants	6.5 years STANDARD_DEVIATION 0.71 • n=4 Participants	6 years STANDARD_DEVIATION 0 • n=21 Participants	12.6 years STANDARD_DEVIATION 3.29 • n=10 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	18 Participants n=10 Participants
Age, Customized Adolescents (12-17 years)	36 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	36 Participants n=10 Participants
Age, Customized Adults (18-64 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Customized From 65 to 84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	27 Participants n=10 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	27 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	53 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	48 Participants n=10 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18)

Population: Population: participants who took at least 1 dose of RPV, regardless of their compliance with protocol \& adherence to dosing regimen. N (Overall number of participants analyzed) =participants evaluable for this outcome measure (OM). In this OM, summarized data for arms "Cohort 2 Children (\>=20 to \<25 kg): Rilpivirine 15 mg" and "Cohort 2 Children (\<20 kg): Rilpivirine 12.5 mg", is not reported as plan was to prepare \& report participant wise data when "N" was \<3 (which is reported in OM 2).

Cmax,ss was the maximum observed plasma concentration of rilpivirine at steady state (steady state starting from Day 14).

Outcome measures

Outcome measures
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=23 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=6 Participants Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg n=4 Participants Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Cohorts 1 and 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Observed Plasma Concentration at Steady State (Cmax,ss)	109 nanograms per milliliter (ng/mL) Standard Deviation 38.0	154 nanograms per milliliter (ng/mL) Standard Deviation 52.2	238 nanograms per milliliter (ng/mL) Standard Deviation 160	—	—

PRIMARY outcome

Timeframe: Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18)

Population: Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. For this OM, participant wise data was only reported because individual data analysis was planned when the 'N' was less than 3.

Cmax,ss was the maximum plasma concentration of rilpivirine at steady state (steady state starting from Day 14). In the below data table, the measure type "Number" corresponds to Cmax,ss concentration.

Outcome measures

Outcome measures
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=2 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=2 Participants Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Cohort 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Plasma Concentration at Steady State (Cmax,ss) Participant 1	138 nanograms per milliliter (ng/mL)	—	—	—	—
Cohort 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Plasma Concentration at Steady State (Cmax,ss) Participant 2	184 nanograms per milliliter (ng/mL)	—	—	—	—
Cohort 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Plasma Concentration at Steady State (Cmax,ss) Participant 3	—	81.9 nanograms per milliliter (ng/mL)	—	—	—
Cohort 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Plasma Concentration at Steady State (Cmax,ss) Participant 4	—	156 nanograms per milliliter (ng/mL)	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18)

Population: Population: participants who took at least 1 dose of RPV, regardless of their compliance with protocol \& adherence to dosing regimen. N (Overall number of participants analyzed) = participants evaluable for this OM. In this OM, summarized data for arms "Cohort 2 Children (\>=20 to \<25 kg): Rilpivirine 15 mg" and "Cohort 2 Children (\<20 kg): Rilpivirine 12.5 mg", is not reported as plan was to prepare \& report participant wise data when "N" was \<3 (which is reported in OM 4).

AUC24,ss was defined as the area under the plasma concentration versus time curve from time 0 to 24 hours post dosing of rilpivirine at steady state (steady state starting from Day 14).

Outcome measures

Outcome measures
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=23 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=6 Participants Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg n=4 Participants Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Cohorts 1 and 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss)	1872 nanogramshour per milliliter (nghr/mL) Standard Deviation 717	2610 nanogramshour per milliliter (nghr/mL) Standard Deviation 776	3339 nanogramshour per milliliter (nghr/mL) Standard Deviation 2233	—	—

PRIMARY outcome

Timeframe: Pre-dose, 0, 2, 4, 5, 6, 9, 12 and 24 hours post dose at steady-state (any time during Day 14 to Day 18)

Outcome measures

Outcome measures
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=2 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=2 Participants Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Cohort 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss) Participant 1	1933 ng*hr/mL	—	—	—	—
Cohort 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss) Participant 2	2877 ng*hr/mL	—	—	—	—
Cohort 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss) Participant 3	—	1710 ng*hr/mL	—	—	—
Cohort 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss) Participant 4	—	2958 ng*hr/mL	—	—	—

SECONDARY outcome

Timeframe: Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From Baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10)

Population: Analysis population included all participants who had taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen.

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and did not necessarily have a causal relationship with the treatment.

Outcome measures

Outcome measures
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=36 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=9 Participants Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg n=5 Participants Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg n=2 Participants Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg n=2 Participants Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Cohorts 1 and 2: Number of Participants With Adverse Events (AEs)	35 Participants	8 Participants	5 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: At Week 48 (for Cohorts 1 and 2) and at Week 240 (for Cohort 1 only)

Population: Population: participants who took at least 1 dose of RPV, regardless of compliance with protocol \& adherence to dosing regimen. In Cohort 2, "0" in "number analyzed" field of Week 240 = Week 240 was not applicable as it was beyond duration of Cohort 2 (Week 48); 0 in number analyzed field of Week 48 =planned TLOVR method was not used for data analysis per PA 10 and thus no data was reported in this OM. 'n' (number analyzed) =number of participants with available data at specified timepoints.

Percentage of participants with plasma HIV-1 RNA \<50 copies per milliliter (Copies/mL) assessed by TLOVR method was reported. TLOVR requires sustained HIV-1 RNA \< 50 copies/mL; confirmed HIV-1 RNA more than or equal to (\>=) 50 copies/mL is considered as non-response (rebound); participant was considered non-responder after permanent discontinuation. Responder is defined as the participant with confirmed plasma viral load \<50 copies/mL. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=36 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Cohorts 1 and 2: Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) Level Less Than (<) 50 Copies/mL by Time to Loss of Virologic Response (TLOVR) Method Week 48	72.2 Percentage of participants	—	—	—	—
Cohorts 1 and 2: Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) Level Less Than (<) 50 Copies/mL by Time to Loss of Virologic Response (TLOVR) Method Week 240	43.8 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: At Week 48 (for Cohorts 1 and 2) and at Week 240 (for Cohort 1 only)

Population: Population:participants who took at least 1 dose of RPV, regardless of compliance with protocol \& adherence to dosing regimen. "N"(Overall number of participants analyzed)=participants evaluable for this OM. "n"(number analyzed)=number of participants with available data at specified timepoints. In Cohort 2, '0' in 'number analyzed' at Week 240=Week 240 was beyond duration of Cohort 2 (Week 48). '0' in 'number analyzed' of Cohort 1 Week 48=snapshot method was not applicable for Cohort 1 Week 48.

Percentage of participants with a HIV-1 RNA \<50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV-1 RNA level is \< 50 copies per mL, it is considered as virologic success as per the snapshot approach. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=32 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=18 Participants Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Cohorts 1 and 2: Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL by Food and Drug Administration (FDA) Snapshot Approach Week 48	—	72.2 Percentage of participants	—	—	—
Cohorts 1 and 2: Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL by Food and Drug Administration (FDA) Snapshot Approach Week 240	53.1 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10)

Number of participants with post baseline genotype (nucleoside analogue reverse transcriptase inhibitors \[NRTI\] and non-nucleoside reverse transcriptase inhibitors \[NNRTI\] resistance) data were reported. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=20 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=6 Participants Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Cohorts 1 and 2: Number of Participants With Post Baseline Genotype Data NNRTI	9 Participants	5 Participants	—	—	—
Cohorts 1 and 2: Number of Participants With Post Baseline Genotype Data NRTI	7 Participants	4 Participants	—	—	—

SECONDARY outcome

Population: Analysis population included all participants who had taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. For Cohort 2, "0" in "number analyzed" field indicated that no participants were available for analysis at Week 240 for Cohort 2 arm because timepoint Week 240 was not applicable to Cohort 2 as it was beyond the duration of Cohort 2 (i.e., Week 48).

Percentage of participants with treatment adherence \>95% based on drug accountability from baseline up to Week 240 for Cohort 1 and from baseline up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) for cohort 2 were reported. Treatment adherence was defined as having a treatment adherence of greater than (\>) 95 percent (%) by pill count. Drug accountability included dispensation, receipt, and return, or if applicable, destruction of RPV documented by using the appropriate forms. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=36 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=18 Participants Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Cohorts 1 and 2: Percentage of Participants With Treatment Adherence >95% Based on Drug Accountability Up to 48 weeks	80.6 Percentage of participants	77.8 Percentage of participants	—	—	—
Cohorts 1 and 2: Percentage of Participants With Treatment Adherence >95% Based on Drug Accountability Up to 240 weeks	77.8 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48 for Cohorts 1 and 2; Week 240 for Cohort 1 alone

Population: Analysis population included all participants who had taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. Here, 'n' (number analyzed) signifies the number of participants with available data at each specified timepoint. "0" participants in "number analyzed field" of cohort 2 indicated that Week 240 was not applicable to Cohort 2 as it was beyond the duration of Cohort 2 (i.e., Week 48).

The immunologic change was determined by changes in Cluster of CD4+ cell count using non-completer =failure imputation, that is discontinuation was imputed with baseline value resulting in change=0, other missing data using last observation carried forward (LOCF). Change from baseline in CD4+ cell count at Week 48 for Cohort 1 and 2; and at Week 240 for Cohort 1 only were assessed. As planned, combined data for cohort 2 was collected, analyzed and reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=36 Participants Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=18 Participants Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Cohorts 1 and 2: Change From Baseline in Cluster of Differentiation (CD4+) Cells Week 48	201.2 Cells per microliter Standard Error 32.87	215.9 Cells per microliter Standard Error 62.42	—	—	—
Cohorts 1 and 2: Change From Baseline in Cluster of Differentiation (CD4+) Cells Week 240	113.6 Cells per microliter Standard Error 26.72	—	—	—	—

Adverse Events

Cohort 1 Adolescents: Rilpivirine 25 mg

Serious events: 6 serious events

Other events: 35 other events

Deaths: 0 deaths

Cohort 2 Children (>=25 kg): Rilpivirine 25 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 2 Children (<25 kg): Rilpivirine 25 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=36 participants at risk Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=9 participants at risk Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg n=5 participants at risk Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg n=2 participants at risk Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg n=2 participants at risk Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Immune system disorders Drug Hypersensitivity	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Abscess Limb	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Lobar Pneumonia	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Malaria	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Psychiatric disorders Suicide Ideation	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Psychiatric disorders Suicidal Attempt	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.

Other adverse events

Other adverse events
Measure	Cohort 1 Adolescents: Rilpivirine 25 mg n=36 participants at risk Adolescents (aged \>=12 to \<18 Years) received rilpivirine (RPV) tablet 25 mg orally QD up to 240 weeks in combination with an investigator-selected background regimen containing 2 nucleos(t)ide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\] or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\].	Cohort 2 Children (>=25 kg): Rilpivirine 25 mg n=9 participants at risk Children (aged \>=6 to \<12 years) with body weight \>=25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<25 kg): Rilpivirine 25 mg n=5 participants at risk Children (aged \>=6 to \<12 years) with body weight \<25 kg received rilpivirine 25 mg tablet orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (>=20 to <25 kg): Rilpivirine 15 mg n=2 participants at risk Children (aged \>=6 to \<12 years) with body weight \>=20 to \<25 kg received rilpivirine 15 mg (6 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.	Cohort 2 Children (<20 kg): Rilpivirine 12.5 mg n=2 participants at risk Children (aged \>=6 to \<12 years) with body weight \<20 kilograms (kg) received rilpivirine 12.5 mg (5 tablets of 2.5 mg) orally QD from Day 1 up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) in combination with an investigator-selected background regimen containing 2 N\[t\]RTIs: AZT, ABC, or TDF in combination with 3TC or FTC.
Blood and lymphatic system disorders Anaemia	11.1% 4/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	50.0% 1/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Blood and lymphatic system disorders Iron Deficiency Anaemia	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Cardiac disorders Rheumatic Heart Disease	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	50.0% 1/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Eye disorders Conjunctivitis	11.1% 4/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Gastrointestinal disorders Abdominal Pain	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Gastrointestinal disorders Constipation	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Gastrointestinal disorders Dental Caries	8.3% 3/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Gastrointestinal disorders Diarrhoea	8.3% 3/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	22.2% 2/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Gastrointestinal disorders Haemorrhoids	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Gastrointestinal disorders Nausea	13.9% 5/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Gastrointestinal disorders Toothache	11.1% 4/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	40.0% 2/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Gastrointestinal disorders Vomiting	8.3% 3/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
General disorders Pyrexia	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Bronchitis	11.1% 4/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Conjunctivitis	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Folliculitis	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Fungal Infection	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Gastroenteritis	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Hepatitis B	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Herpes Simplex	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Impetigo	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Influenza	41.7% 15/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	50.0% 1/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Malaria	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	50.0% 1/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Nasopharyngitis	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Oral Herpes	8.3% 3/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Otitis Media	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	50.0% 1/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Pharyngitis	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Pneumonia	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Respiratory Tract Infection	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Sinusitis	8.3% 3/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Tonsillitis	8.3% 3/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Upper Respiratory Tract Infection	55.6% 20/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	55.6% 5/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	60.0% 3/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	100.0% 2/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	100.0% 2/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Infections and infestations Urinary Tract Infection	11.1% 4/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Investigations Acth Stimulation Test Abnormal	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Investigations Alanine Aminotransferase Increased	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Investigations Aspartate Aminotransferase Increased	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Investigations Blood Alkaline Phosphatase Increased	8.3% 3/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Investigations Blood Cortisol Decreased	19.4% 7/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Investigations Electrocardiogram QT Prolonged	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Investigations Protein Total Increased	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Investigations Weight Decreased	11.1% 4/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Metabolism and nutrition disorders Decreased Appetite	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	22.2% 2/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Nervous system disorders Dizziness	11.1% 4/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Nervous system disorders Headache	25.0% 9/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Nervous system disorders Somnolence	13.9% 5/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Psychiatric disorders Depression	19.4% 7/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Renal and urinary disorders Haematuria	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Renal and urinary disorders Proteinuria	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Reproductive system and breast disorders Vaginal Discharge	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Respiratory, thoracic and mediastinal disorders Cough	27.8% 10/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	50.0% 1/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Respiratory, thoracic and mediastinal disorders Productive Cough	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Skin and subcutaneous tissue disorders Dermatitis	2.8% 1/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	50.0% 1/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Skin and subcutaneous tissue disorders Rash	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	50.0% 1/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Surgical and medical procedures Tooth Extraction	5.6% 2/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	11.1% 1/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/36 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/9 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	20.0% 1/5 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.	0.00% 0/2 • Cohort 1: From baseline (Day 1) up to Week 240; Cohort 2: From baseline (Day 1) up to 240 weeks (for participants recruited up to protocol amendment 9); up to 48 weeks (for participants recruited after implementation of protocol amendment 10) Analysis population included all participants who had taken at least 1 dose of rilpivirine, regardless of their compliance with the protocol and adherence to the dosing regimen. MedDRA 13.1 was used for Cohort 1 arm and MedDRA 25.0 was used for Cohort 2 arms.

Additional Information

Director 1 Clinical Leader

Janssen R&D BE

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER