Trial Outcomes & Findings for FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women (NCT NCT00625404)

NCT ID: NCT00625404

Last Updated: 2018-07-26

Results Overview

HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2120 participants
• Primary outcome timeframe: Cumulative HIV infection between enrollment and 52 weeks
• Results posted on: 2018-07-26

Participant Flow

Participant milestones

Measure	Truvada Arm Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).	Placebo Arm Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Overall Study STARTED	1062	1058
Overall Study COMPLETED	855	885
Overall Study NOT COMPLETED	207	173

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women

Baseline characteristics by cohort

Measure	Truvada Arm n=1062 Participants Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.	Placebo Arm n=1058 Participants Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.	Total n=2120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1062 Participants n=5 Participants	1058 Participants n=7 Participants	2120 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	23 years FULL_RANGE 18-35 • n=5 Participants	23 years FULL_RANGE 18-35 • n=7 Participants	23 years FULL_RANGE 18-35 • n=5 Participants
Sex: Female, Male Female	1062 Participants n=5 Participants	1058 Participants n=7 Participants	2120 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Cumulative HIV infection between enrollment and 52 weeks

Population: All randomized participants who made at least one follow-up visit and were not HIV-positive at enrollment were included in the analysis population

HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.

Outcome measures

Measure	Truvada Arm n=1024 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=1032 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
HIV Infection	33 participants Interval 3.25 to 6.63	35 participants Interval 3.47 to 6.93

PRIMARY outcome

Timeframe: cumulative toxicity through 52 weeks of product use and 4 weeks post product

Population: The Safety Population consisted of all women who were randomized and who had at least one follow-up visit and did not return all of their product un-used. Only women assessed for a particular safety outcome were included in analysis of that outcome.

Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal

Outcome measures

Measure	Truvada Arm n=1021 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=1033 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
Confirmed Grade 2 or Higher Serum Creatinine Toxicity	4 participants	2 participants

PRIMARY outcome

Timeframe: 10-26 months per site

Population: The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.

The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration.

Outcome measures

Measure	Truvada Arm n=1025 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=1033 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration	2257 Number of adverse events	2384 Number of adverse events

PRIMARY outcome

Timeframe: Through 52 weeks on product and 4 weeks post-product

Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL

Outcome measures

Measure	Truvada Arm n=1021 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=1033 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
Confirmed Grade 3 or Higher Reduction in Phosphorus	45 participants	40 participants

PRIMARY outcome

Timeframe: Through 52 weeks on product and 4 weeks post-product

Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal

Outcome measures

Measure	Truvada Arm n=1021 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=1033 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
Confirmed Grade 3 or Higher ALT Elevation	6 participants	8 participants

PRIMARY outcome

Timeframe: Through 52 weeks on product and 4 weeks post-product

Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal

Outcome measures

Measure	Truvada Arm n=1021 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=1033 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
Confirmed Grade 3 or Higher AST Elevation	3 participants	1 participants

SECONDARY outcome

Timeframe: up to 16 weeks

Population: 68 women who became infected post-enrollment were included in viral load analyses. Only 48 of these women (27 on Truvada and 21 on placebo) contributed a specimen sample for analysis at the 16-weeks post seroconversion visit

Viral load at the time of HIV detection, HIV conversion and through 16 weeks

Outcome measures

Measure	Truvada Arm n=27 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=21 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
Plasma HIV RNA Level (HIV-1 Viral Load)	4.40 log copies/mL Standard Deviation 1.05	4.37 log copies/mL Standard Deviation 1.08

SECONDARY outcome

Timeframe: Up to 16 weeks

CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks

Outcome measures

Measure	Truvada Arm n=26 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=20 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
CD4+ T-cell Count	579.3 cells/mL Standard Deviation 318.2	601.4 cells/mL Standard Deviation 318.5

SECONDARY outcome

Timeframe: up to 52 weeks

Population: All women who seroconverted were assessed for possible resistance.

Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).

participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time.

Outcome measures

Measure	Truvada Arm n=33 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=35 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
FTC and/or Tenofovir Resistance	3 participants	1 participants

SECONDARY outcome

Timeframe: up to 60 weeks

Population: Women becoming pregnant during regular follow-up in the study (70 in Truvada group and 45 in placebo group)

Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications

Outcome measures

Measure	Truvada Arm n=70 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=45 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
Pregnancy Complications	20 participants	10 participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: All randomized participants who completed at least one follow-up visit, excluding women found to have been infected at enrollment

Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts

Outcome measures

Measure	Truvada Arm n=1024 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=1032 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
Pill Counts and Participant Report of Adherence to Once-daily Pill Taking	87 percentage of days Standard Deviation 0.20	89 percentage of days Standard Deviation 0.17

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Women reporting on sexual behavior during follow-up

Difference in mean number of reported sexual partners between final study visit and enrollment visit

Outcome measures

Measure	Truvada Arm n=977 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.	Placebo Arm n=989 Participants The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
Participant Report of Change in Number of Sexual Partners	-0.14 mean number of sexual partners Standard Deviation 0.60 • Interval 0.0 to 6.0	-0.13 mean number of sexual partners Standard Deviation 0.79 • Interval 0.0 to 11.0

Adverse Events

Truvada Arm

Serious events: 33 serious events

Other events: 761 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 23 serious events

Other events: 749 other events

Deaths: 0 deaths

Serious adverse events

Measure	Truvada Arm n=1025 participants at risk Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).	Placebo Arm n=1033 participants at risk Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Blood and lymphatic system disorders anemia	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Congenital, familial and genetic disorders exomphalos	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders typhoid fever	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders gastroenteritis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations malaria	0.39% 4/1025 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.29% 3/1033 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations pneumonia	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations respiratory tract infection	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations tuberculosis	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Bartholin's abscess	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations influenza	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations pelvic inflammatory disease	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations urinary tract infection	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications fracture	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications wound	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications abdominal injury	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications joint sprain	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders joint contracture	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders joint dislocation	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders syncope	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders muscular weakness	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders neuropathy peripheral	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions abortion	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions ectopic pregnancy	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions foetal distress syndrome	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions premature rupture of the membranes	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Psychiatric disorders intentional overdose	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Psychiatric disorders depression	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Psychiatric disorders withdrawal syndrome	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders menorrhagia	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders asthma	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Surgical and medical procedures removal of foreign body	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Vascular disorders hypotension	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.

Other adverse events

Measure	Truvada Arm n=1025 participants at risk Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).	Placebo Arm n=1033 participants at risk Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Blood and lymphatic system disorders Anaemia	0.59% 6/1025 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.48% 5/1033 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Blood and lymphatic system disorders Lymphadenopathy	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Cardiac disorders Palpitations	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Congenital, familial and genetic disorders Exomphalos	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Ear and labyrinth disorders Ear pain	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.48% 5/1033 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Ear and labyrinth disorders Otorrhoea	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Eye disorders Eye pain	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.39% 4/1033 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Eye disorders Abnormal vision	0.10% 1/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Eye disorders Dry eye	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Eye disorders Eye pruritus	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Eye disorders Photophobia	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Eye disorders Vision blurred	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Eye disorders Visual acuity reduced	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Nausea	4.9% 50/1025 • Number of events 52 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	3.1% 32/1033 • Number of events 33 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Abdominal pain	2.6% 27/1025 • Number of events 27 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	2.6% 27/1033 • Number of events 27 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Vomiting	3.6% 37/1025 • Number of events 38 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.2% 12/1033 • Number of events 12 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Typhoid fever	2.3% 24/1025 • Number of events 25 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.4% 14/1033 • Number of events 17 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Gastroenteritis	2.0% 21/1025 • Number of events 21 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.4% 14/1033 • Number of events 16 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Diarrhoea	1.7% 17/1025 • Number of events 18 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.6% 17/1033 • Number of events 21 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Dyspepsia	1.1% 11/1025 • Number of events 11 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.5% 16/1033 • Number of events 17 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Toothache	1.3% 13/1025 • Number of events 15 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.68% 7/1033 • Number of events 7 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Gastritis	0.78% 8/1025 • Number of events 8 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.1% 11/1033 • Number of events 11 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Dysentery	0.68% 7/1025 • Number of events 8 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.48% 5/1033 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Flatulence	0.49% 5/1025 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.58% 6/1033 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Dental caries	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.29% 3/1033 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Peptic ulcer	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Abdominal distension	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Aphthous stomatitis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Colitis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Constipation	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Haemorrhoids	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Cheilitis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Gingival pain	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Gingivitis	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Hyperphagia	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Mouth ulceration	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Odynophagia	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Rectal prolapse	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Stomatitis	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Gastrointestinal disorders Umbilical hernia	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
General disorders Fatigue	1.7% 17/1025 • Number of events 17 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.77% 8/1033 • Number of events 8 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
General disorders Malaise	0.68% 7/1025 • Number of events 8 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.1% 11/1033 • Number of events 11 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
General disorders Pain	0.39% 4/1025 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
General disorders Oedema peripheral	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.29% 3/1033 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
General disorders Pyrexia	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
General disorders Chills	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
General disorders Local swelling	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
General disorders Procedural pain	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
General disorders Thirst	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Hepatobiliary disorders Cholecystitis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Immune system disorders Dermatitis allergic	2.9% 30/1025 • Number of events 33 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	2.0% 21/1033 • Number of events 21 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Immune system disorders Pruritus allergic	1.1% 11/1025 • Number of events 12 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.58% 6/1033 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Immune system disorders Conjunctivitis allergic	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.87% 9/1033 • Number of events 9 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Immune system disorders Hypersensitivity	0.78% 8/1025 • Number of events 8 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Immune system disorders Rhinitis allergic	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.39% 4/1033 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Immune system disorders Allergic cough	0.20% 2/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Immune system disorders Allergic sinusitis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Immune system disorders Idiopathic urticaria	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Malaria	12.0% 123/1025 • Number of events 154 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	11.7% 121/1033 • Number of events 157 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Respiratory tract infection	9.4% 96/1025 • Number of events 108 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	10.5% 108/1033 • Number of events 125 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Vaginitis bacterial	6.5% 67/1025 • Number of events 69 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	7.8% 81/1033 • Number of events 81 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Candidiasis	5.9% 60/1025 • Number of events 62 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	5.0% 52/1033 • Number of events 57 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Chlamydial infection	3.4% 35/1025 • Number of events 35 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	3.7% 38/1033 • Number of events 39 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Urinary tract infection	2.2% 23/1025 • Number of events 23 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	3.3% 34/1033 • Number of events 38 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Nasopharyngitis	1.9% 19/1025 • Number of events 21 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	3.5% 36/1033 • Number of events 42 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Tonsillitis	2.2% 23/1025 • Number of events 28 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	2.2% 23/1033 • Number of events 26 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Tinea infection	1.8% 18/1025 • Number of events 18 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.8% 19/1033 • Number of events 22 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Pelvic inflammatory disease	1.6% 16/1025 • Number of events 16 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.9% 20/1033 • Number of events 20 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Vaginal infection	2.0% 20/1025 • Number of events 23 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.2% 12/1033 • Number of events 12 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Trichomoniasis	1.3% 13/1025 • Number of events 13 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.5% 16/1033 • Number of events 16 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Influenza	1.3% 13/1025 • Number of events 14 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.4% 14/1033 • Number of events 16 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Pneumonia	1.2% 12/1025 • Number of events 13 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.3% 13/1033 • Number of events 14 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Cervicitis	1.1% 11/1025 • Number of events 11 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.97% 10/1033 • Number of events 10 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Abscess	0.88% 9/1025 • Number of events 9 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.77% 8/1033 • Number of events 8 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Gonorrhoea	0.98% 10/1025 • Number of events 10 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.48% 5/1033 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Sinusitis	0.68% 7/1025 • Number of events 7 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Furuncle	0.49% 5/1025 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.29% 3/1033 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Tuberculosis	0.39% 4/1025 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Vulvovaginitis	0.39% 4/1025 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Wound infection	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.29% 3/1033 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Eye infection	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Oral herpes	0.39% 4/1025 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Pharyngitis	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Herpes zoster	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Otitis externa	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Pyelonephritis	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.29% 3/1033 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Helminthic infection	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Hordeolum	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Otitis media	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Amoebiasis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Bartholin's abscess	0.10% 1/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Bronchopneumonia	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Cellulitis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Ear infection	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Extrapulmonary tuberculosis	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Herpes simplex	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Parotitis	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Infections and infestations Rhinitis	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Wound	0.49% 5/1025 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.1% 11/1033 • Number of events 11 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Joint sprain	0.49% 5/1025 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Animal bite	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.29% 3/1033 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Fracture	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Human bite	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Incision site pain	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Periorbital haematoma	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Thermal burn	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Abdominal injury	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Anthropod sting	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Contusion	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Contusion of knee	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Face injury	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Injury	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Mouth injury	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Blood phosphorus decreased	19.4% 199/1025 • Number of events 267 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	18.3% 189/1033 • Number of events 257 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Aspartate aminotransferase increased	13.1% 134/1025 • Number of events 177 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	11.5% 119/1033 • Number of events 147 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Alanine aminotransferase increased	11.6% 119/1025 • Number of events 162 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	10.6% 110/1033 • Number of events 125 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Blood phosphorus increased	9.1% 93/1025 • Number of events 103 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	9.9% 102/1033 • Number of events 121 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Blood creatinine increased	6.8% 70/1025 • Number of events 95 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	6.5% 67/1033 • Number of events 79 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Liver function test abnormal	2.5% 26/1025 • Number of events 35 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.7% 18/1033 • Number of events 19 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Blood bicarbonate decreased	1.2% 12/1025 • Number of events 13 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.9% 20/1033 • Number of events 22 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Eosinophil count increased	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Platelet count increased	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Creatinine renal clearance decreased	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Glucose urine	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Haemoglobin decreased	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Heart rate decreased	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Hormonal level abnormal	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Renal function test abnormal	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Investigations Weight decreased	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Metabolism and nutrition disorders Decreased appetite	0.98% 10/1025 • Number of events 10 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.39% 4/1033 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Metabolism and nutrition disorders Anorexia	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Metabolism and nutrition disorders Dehydration	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Back pain	2.0% 21/1025 • Number of events 22 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	2.4% 25/1033 • Number of events 26 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 14/1025 • Number of events 15 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.58% 6/1033 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Myalgia	0.59% 6/1025 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.97% 10/1033 • Number of events 12 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Soft tissue injury	0.78% 8/1025 • Number of events 9 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.48% 5/1033 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.39% 4/1025 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.48% 5/1033 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Arthritis	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.39% 4/1033 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Neck pain	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.29% 3/1033 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Joint contracture	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Joint dislocation	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Muscle mass	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Pain in extremity	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Headache	13.1% 134/1025 • Number of events 153 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	14.3% 148/1033 • Number of events 173 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Dizziness	5.1% 52/1025 • Number of events 56 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	4.4% 45/1033 • Number of events 46 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Hypoaesthesia	0.49% 5/1025 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.29% 3/1033 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Neuropathy peripheral	0.39% 4/1025 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Syncope	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Paraesthesia	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Insomnia	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Somnolence	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Burning sensation	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Hemiparesis	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Muscular weakness	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Neuritis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Nervous system disorders Vision blurred	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions Abortion	1.1% 11/1025 • Number of events 11 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.68% 7/1033 • Number of events 7 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions Vomiting in pregnancy	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions Premature rupture of the membranes	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Pregnancy, puerperium and perinatal conditions Somatoform disorder pregnancy	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Psychiatric disorders Intentional overdose	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Psychiatric disorders Anxiety	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Psychiatric disorders Depression	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Psychiatric disorders Mood swings	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Psychiatric disorders Panic attack	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Psychiatric disorders Withdrawal syndrome	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Renal and urinary disorders Dysuria	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Renal and urinary disorders Proteinuria	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Renal and urinary disorders Haematuria	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Renal and urinary disorders Urinary incontinence	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Vaginal discharge	1.9% 19/1025 • Number of events 22 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.3% 13/1033 • Number of events 14 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Dysfunctional uterine bleeding	1.7% 17/1025 • Number of events 18 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.3% 13/1033 • Number of events 13 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Metrorrhagia	0.98% 10/1025 • Number of events 10 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	1.4% 14/1033 • Number of events 15 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Menorrhagia	1.2% 12/1025 • Number of events 12 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.87% 9/1033 • Number of events 9 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Dysmenorrhoea	0.78% 8/1025 • Number of events 8 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.58% 6/1033 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Genital ulceration	0.98% 10/1025 • Number of events 10 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Pelvic pain	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.39% 4/1033 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Vulvovaginal pruritus	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.48% 5/1033 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Premenstrual syndrome	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Breast discomfort	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Breast pain	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Coital bleeding	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Dyspareunia	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Galacthorrhoea	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Genital erosion	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Ovarian cyst	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Uterine leiomyoma	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Reproductive system and breast disorders Vaginal ulceration	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.3% 13/1025 • Number of events 13 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.48% 5/1033 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Cough	0.59% 6/1025 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.48% 5/1033 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Asthma	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.39% 4/1033 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.39% 4/1033 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Chest pain	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.39% 4/1033 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Rash	0.59% 6/1025 • Number of events 6 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.97% 10/1033 • Number of events 10 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Pruritus generalised	0.39% 4/1025 • Number of events 4 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.48% 5/1033 • Number of events 5 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Pruritus	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Acne	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Angioedema	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Chloasma	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Dermatitis	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Skin exfoliation	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Skin ulcer	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Skin and subcutaneous tissue disorders Urticaria	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Social circumstances Physical assault	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Surgical and medical procedures Removal of foreign body	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.10% 1/1033 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Vascular disorders Hypertension	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Vascular disorders Venous insufficiency	0.29% 3/1025 • Number of events 3 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Vascular disorders Hypotension	0.20% 2/1025 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Vascular disorders Varicose vein	0.00% 0/1025 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.19% 2/1033 • Number of events 2 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Vascular disorders Lymphoedema	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.
Vascular disorders Orthostatic hypotension	0.10% 1/1025 • Number of events 1 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.	0.00% 0/1033 These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.

Additional Information

Jennifer Deese, Principal Investigator

FHI 360

Phone: 919-544-7040

Email: jdeese@fhi360.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place