Trial Outcomes & Findings for Comparative Study of Three NNRTI-Sparing HAART Regimens (NCT NCT00811954)

NCT ID: NCT00811954

Last Updated: 2014-09-05

Results Overview

The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96. Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA \>1000 copies/mL at or after week 16 and before week 24, or \>200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1814 participants
• Primary outcome timeframe: From study entry to week 96
• Results posted on: 2014-09-05

Participant Flow

Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between May 22, 2009 (date first subject was randomized) and June 9, 2011 (date last subject was randomized).

1814 were randomized 1:1:1 to treatment arms A, B, and C. Results reported for 1809 eligible participants; 5 were subsequently found ineligible and excluded from all analyses.

Participant milestones

Measure	Arm A: ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Overall Study STARTED	605	603	601
Overall Study COMPLETED	516	531	500
Overall Study NOT COMPLETED	89	72	101

Reasons for withdrawal

Measure	Arm A: ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Overall Study Death	10	6	13
Overall Study Lost to Follow-up	29	23	34
Overall Study Not able to get to clinic	28	35	30
Overall Study Not willing to adhere to requirements	12	2	16
Overall Study Withdraw consent prior study completion	4	6	5
Overall Study Site Closure	4	0	1
Overall Study Severe Debilitation	2	0	1
Overall Study Complete Protocol: No follow-up	0	0	1

Baseline Characteristics

Comparative Study of Three NNRTI-Sparing HAART Regimens

Baseline characteristics by cohort

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)	Total n=1809 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	597 Participants n=5 Participants	598 Participants n=7 Participants	595 Participants n=5 Participants	1790 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Age, Continuous	38 years STANDARD_DEVIATION 11 • n=5 Participants	37 years STANDARD_DEVIATION 11 • n=7 Participants	38 years STANDARD_DEVIATION 11 • n=5 Participants	37 years STANDARD_DEVIATION 11 • n=4 Participants
Sex: Female, Male Female	144 Participants n=5 Participants	148 Participants n=7 Participants	143 Participants n=5 Participants	435 Participants n=4 Participants
Sex: Female, Male Male	461 Participants n=5 Participants	455 Participants n=7 Participants	458 Participants n=5 Participants	1374 Participants n=4 Participants
Race/Ethnicity, Customized White Non-Hispanic	212 participants n=5 Participants	212 participants n=7 Participants	191 participants n=5 Participants	615 participants n=4 Participants
Race/Ethnicity, Customized Black Non-Hispanic	252 participants n=5 Participants	254 participants n=7 Participants	251 participants n=5 Participants	757 participants n=4 Participants
Race/Ethnicity, Customized Hispanic (Regardless of Race)	125 participants n=5 Participants	117 participants n=7 Participants	148 participants n=5 Participants	390 participants n=4 Participants
Race/Ethnicity, Customized Asian, Pacific Islander	11 participants n=5 Participants	13 participants n=7 Participants	6 participants n=5 Participants	30 participants n=4 Participants
Race/Ethnicity, Customized American Indian, Alaskan Native	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Race/Ethnicity, Customized More than one race	2 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	7 participants n=4 Participants
Race/Ethnicity, Customized Unknown/missing	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants
HIV-1 RNA	4.6 log10 copies/mL STANDARD_DEVIATION 0.7 • n=5 Participants	4.6 log10 copies/mL STANDARD_DEVIATION 0.7 • n=7 Participants	4.6 log10 copies/mL STANDARD_DEVIATION 0.7 • n=5 Participants	4.6 log10 copies/mL STANDARD_DEVIATION 0.7 • n=4 Participants
CD4+ T-cell count	309 cells/mm^3 STANDARD_DEVIATION 189 • n=5 Participants	306 cells/mm^3 STANDARD_DEVIATION 199 • n=7 Participants	310 cells/mm^3 STANDARD_DEVIATION 189 • n=5 Participants	308 cells/mm^3 STANDARD_DEVIATION 192 • n=4 Participants

PRIMARY outcome

Timeframe: From study entry to week 96

Population: Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.

Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Cumulative Probability of First Virologic Failure by Week 96	13 cumulative probability per 100 persons Interval 10.0 to 16.0	10 cumulative probability per 100 persons Interval 7.0 to 12.0	15 cumulative probability per 100 persons Interval 12.0 to 18.0

PRIMARY outcome

Timeframe: From study entry to week 96

Population: Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96	14 cumulative events per 100 persons Interval 12.0 to 17.0	1 cumulative events per 100 persons Interval 1.0 to 3.0	5 cumulative events per 100 persons Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: From study entry to week 96

Population: As treated: Participants who had events occurring while on randomized treatment are included in this analysis: grade 2 events occurring in the after 48 weeks on study are excluded. Participants were analyzed per original assigned randomized treatment.

The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.

The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=600 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=599 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=597 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Cumulative Incidence of First Adverse Event by Week 96	81 cumulative events per 100 persons Interval 77.0 to 84.0	59 cumulative events per 100 persons Interval 55.0 to 63.0	65 cumulative events per 100 persons Interval 61.0 to 69.0

SECONDARY outcome

Timeframe: From study entry to week 96

Population: Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.

A composite TLOVR endpoint defined in the CDER of the FDA document "Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval" (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.

If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96	31 cumulative probability per 100 persons Interval 27.0 to 35.0	16 cumulative probability per 100 persons Interval 14.0 to 19.0	24 cumulative probability per 100 persons Interval 20.0 to 27.0

SECONDARY outcome

Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)

Population: Participants who met the criteria for virologic failure with successful sequencing at virologic failure

The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=75 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=65 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=99 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Presence of Mutations Associated With NRTI Resistance	8 participants	7 participants	3 participants

SECONDARY outcome

Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)

Population: Participants who met the criteria for virologic failure with successful sequencing at virologic failure

The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=75 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=65 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=99 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)

Population: Participants who met the criteria for virologic failure restricted to participants in the RAL group and random sample of participants in PI/RTV groups with successful sequencing at virologic failure.

The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=15 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=46 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=14 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Presence of Mutations Associated With INI Resistance	1 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: At Weeks 24, 48, 96, and 144

Population: Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.

The absolute levels of CD4+ T-cell counts (cells/mm3)

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
CD4+ T-cell Count week 144 (nA=395, nB=418, nC=394)	622 cells/mm^3 Interval 596.0 to 648.0	631 cells/mm^3 Interval 602.0 to 660.0	596 cells/mm^3 Interval 571.0 to 622.0
CD4+ T-cell Count week 24 (nA=582, nB=574, nC=579)	462 cells/mm^3 Interval 443.0 to 480.0	460 cells/mm^3 Interval 440.0 to 480.0	457 cells/mm^3 Interval 438.0 to 476.0
CD4+ T-cell Count week 48 (nA=564, nB=565, nC=559)	524 cells/mm^3 Interval 504.0 to 544.0	526 cells/mm^3 Interval 504.0 to 549.0	509 cells/mm^3 Interval 488.0 to 529.0
CD4+ T-cell Count week 96 (nA=523, nB=541, nC=525)	587 cells/mm^3 Interval 565.0 to 609.0	596 cells/mm^3 Interval 573.0 to 619.0	564 cells/mm^3 Interval 541.0 to 586.0

SECONDARY outcome

Timeframe: Study entry to weeks 24, 48, 96, and 144

Population: Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.

Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
CD4+ T-cell Count Changes From Baseline week 24 (nA=582, nB=574, nC=579)	157 cells/mm^3 Interval 147.0 to 167.0	153 cells/mm^3 Interval 142.0 to 163.0	147 cells/mm^3 Interval 136.0 to 157.0
CD4+ T-cell Count Changes From Baseline week 48 (nA=564, nB=565, nC=559)	218 cells/mm^3 Interval 206.0 to 231.0	218 cells/mm^3 Interval 205.0 to 232.0	201 cells/mm^3 Interval 187.0 to 214.0
CD4+ T-cell Count Changes From Baseline week 96 (nA=523, nB=541, nC=525)	284 cells/mm^3 Interval 269.0 to 300.0	288 cells/mm^3 Interval 272.0 to 304.0	256 cells/mm^3 Interval 240.0 to 271.0
CD4+ T-cell Count Changes From Baseline week 144 (nA=395, nB=418, nC=394)	324 cells/mm^3 Interval 305.0 to 343.0	325 cells/mm^3 Interval 304.0 to 345.0	288 cells/mm^3 Interval 269.0 to 307.0

SECONDARY outcome

Timeframe: Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable

Population: Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Incidence of Death or AIDS Defining Events (CDC Category C)	1.55 events per 100 person-years Interval 1.05 to 2.28	1.64 events per 100 person-years Interval 1.12 to 2.4	2.14 events per 100 person-years Interval 1.43 to 3.2

SECONDARY outcome

Timeframe: Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable

Population: Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

The incidence of targeted serious non-AIDS defining events was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)	2.38 events per 100 person-years Interval 1.76 to 3.23	2.24 events per 100 person-years Interval 1.51 to 3.32	2.69 events per 100 person-years Interval 1.89 to 3.84

SECONDARY outcome

Timeframe: Study entry to weeks 48, 96, and 144

Population: Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Change in Fasting Total Cholesterol Level From Baseline week 48 (nA=521, nB=542, nC=507)	13 mg/dL Interval 10.0 to 16.0	1 mg/dL Interval -2.0 to 3.0	15 mg/dL Interval 12.0 to 18.0
Change in Fasting Total Cholesterol Level From Baseline week 96 (nA=490, nB=505, nC=490)	16 mg/dL Interval 13.0 to 19.0	3 mg/dL Interval 1.0 to 6.0	14 mg/dL Interval 11.0 to 17.0
Change in Fasting Total Cholesterol Level From Baseline week 144 (nA=364, nB=397, nC=363)	20 mg/dL Interval 15.0 to 25.0	6 mg/dL Interval 2.0 to 9.0	19 mg/dL Interval 16.0 to 23.0

SECONDARY outcome

Timeframe: Study entry to weeks 48, 96, and 144

Population: Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Change in Fasting HDL Cholesterol Level From Baseline week 48 (nA=522, nB=542, nC=506)	6 mg/dL Interval 5.0 to 7.0	5 mg/dL Interval 4.0 to 6.0	5 mg/dL Interval 4.0 to 6.0
Change in Fasting HDL Cholesterol Level From Baseline week 96 (nA=490, nB=505, nC=488)	7 mg/dL Interval 5.0 to 8.0	6 mg/dL Interval 5.0 to 7.0	5 mg/dL Interval 4.0 to 6.0
Change in Fasting HDL Cholesterol Level From Baseline week 144 (nA=364, nB=397, nC=363)	8 mg/dL Interval 7.0 to 9.0	6 mg/dL Interval 5.0 to 7.0	7 mg/dL Interval 6.0 to 8.0

SECONDARY outcome

Timeframe: Study entry to weeks 48, 96, and 144

Population: Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Change in Fasting Triglycerides Level From Baseline week 48 (nA=522, nB=542, nC=507)	18 mg/dL Interval 11.0 to 24.0	-9 mg/dL Interval -16.0 to -3.0	16 mg/dL Interval 8.0 to 24.0
Change in Fasting Triglycerides Level From Baseline week 96 (nA=490, nB=505, nC=490)	19 mg/dL Interval 12.0 to 27.0	-9 mg/dL Interval -16.0 to -1.0	16 mg/dL Interval 7.0 to 25.0
Change in Fasting Triglycerides Level From Baseline week 144 (nA=364, nB=397, nC=363)	12 mg/dL Interval 4.0 to 19.0	-4 mg/dL Interval -13.0 to 4.0	20 mg/dL Interval 10.0 to 30.0

SECONDARY outcome

Timeframe: Study entry to weeks 48, 96, and 144

Population: Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Change in Fasting Plasma Glucose Level From Baseline week 48 (nA=517, nB=535, nC=506)	2.2 mg/dL Interval 0.7 to 3.8	1.3 mg/dL Interval -0.3 to 2.8	2.1 mg/dL Interval 0.8 to 3.4
Change in Fasting Plasma Glucose Level From Baseline week 96 (nA=489, nB=499, nC=481)	3.0 mg/dL Interval 1.4 to 4.6	0.9 mg/dL Interval -0.6 to 2.5	2.5 mg/dL Interval 0.5 to 4.5
Change in Fasting Plasma Glucose Level From Baseline week 144 (nA=353, nB=392, nC=358)	2.2 mg/dL Interval -0.8 to 5.2	0.9 mg/dL Interval -1.6 to 3.4	3.6 mg/dL Interval 1.1 to 6.0

SECONDARY outcome

Timeframe: Study entry to weeks 48, 96, and 144

Population: Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.

Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Change in Framingham 10-year Risk of MI or Coronary Death From Baseline week 48 (nA=509, nB=537, nC=492)	0.4 percent risk Interval 0.2 to 0.6	0.0 percent risk Interval -0.2 to 0.1	0.4 percent risk Interval 0.2 to 0.6
Change in Framingham 10-year Risk of MI or Coronary Death From Baseline week 96 (nA=479, nB=493, nC=470)	0.5 percent risk Interval 0.3 to 0.7	0.2 percent risk Interval 0.0 to 0.4	0.4 percent risk Interval 0.2 to 0.6
Change in Framingham 10-year Risk of MI or Coronary Death From Baseline week 144 (nA=347, nB=383, nC=349)	0.6 percent risk Interval 0.3 to 0.8	0.4 percent risk Interval 0.2 to 0.7	0.9 percent risk Interval 0.6 to 1.2

SECONDARY outcome

Timeframe: Study entry to weeks 48, 96, and 144

Population: Intention to treat: All participants with waist circumference data were included, complete-case approach.

Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Change in Waist Circumference From Baseline week 48 (nA=555, nB=551, nC=547)	2.3 cm Interval 1.7 to 2.9	3.1 cm Interval 2.5 to 3.7	2.1 cm Interval 1.5 to 2.6
Change in Waist Circumference From Baseline week 96 (nA=512, nB=526, nC=517)	3.3 cm Interval 2.6 to 4.0	4.0 cm Interval 3.3 to 4.7	2.8 cm Interval 2.2 to 3.5
Change in Waist Circumference From Baseline week 144 (nA=425, nB=419, nC=409)	3.6 cm Interval 2.9 to 4.4	4.0 cm Interval 3.2 to 4.8	3.4 cm Interval 2.7 to 4.2

SECONDARY outcome

Timeframe: Study entry to weeks 48, 96, and 144

Population: Intention to treat: All participants with waist circumference data were included, complete-case approach.

Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Change in Waist:Height Ratio From Baseline week 48 (nA=555, nB=551, nC=547)	0.01 cm:cm Interval 0.01 to 0.02	0.02 cm:cm Interval 0.01 to 0.02	0.01 cm:cm Interval 0.01 to 0.02
Change in Waist:Height Ratio From Baseline week 96 (nA=512, nB=526, nC=517)	0.02 cm:cm Interval 0.02 to 0.02	0.02 cm:cm Interval 0.02 to 0.03	0.02 cm:cm Interval 0.01 to 0.02
Change in Waist:Height Ratio From Baseline week 144 (nA=425, nB=419, nC=409)	0.02 cm:cm Interval 0.02 to 0.03	0.02 cm:cm Interval 0.02 to 0.03	0.02 cm:cm Interval 0.02 to 0.02

SECONDARY outcome

Timeframe: At Weeks 4, 24, 48, 96, and 144

Population: Intention to treat: All participants with fasting self-reported adherence data were included.

Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144.

Outcome measures

Measure	Arm A: ATV/RTV + FTC/TDF n=605 Participants Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 Participants FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 Participants FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Self-reported Adherence week 4 (nA=584, nB=590, nC=583)	98 percentage of prescribed medication Interval 98.0 to 99.0	97 percentage of prescribed medication Interval 97.0 to 98.0	98 percentage of prescribed medication Interval 98.0 to 99.0
Self-reported Adherence week 24 (nA=570, nB=568, nC=562)	97 percentage of prescribed medication Interval 96.0 to 98.0	97 percentage of prescribed medication Interval 96.0 to 97.0	96 percentage of prescribed medication Interval 95.0 to 97.0
Self-reported Adherence week 48 (nA=555, nB=547, nC=536)	96 percentage of prescribed medication Interval 95.0 to 97.0	97 percentage of prescribed medication Interval 96.0 to 97.0	96 percentage of prescribed medication Interval 95.0 to 97.0
Self-reported Adherence week 96 (nA=508, nB=525, nC=507)	96 percentage of prescribed medication Interval 94.0 to 97.0	96 percentage of prescribed medication Interval 95.0 to 97.0	96 percentage of prescribed medication Interval 95.0 to 97.0
Self-reported Adherence week 144 (nA=361, nB=376, nC=350)	97 percentage of prescribed medication Interval 96.0 to 98.0	97 percentage of prescribed medication Interval 96.0 to 97.0	98 percentage of prescribed medication Interval 97.0 to 98.0

Adverse Events

Arm A: ATV/RTV + FTC/TDF

Serious events: 139 serious events

Other events: 565 other events

Deaths: 0 deaths

Arm B: RAL + FTC/TDF

Serious events: 126 serious events

Other events: 516 other events

Deaths: 0 deaths

Arm C: DRV/RTV + FTC/TDF

Serious events: 125 serious events

Other events: 532 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A: ATV/RTV + FTC/TDF n=605 participants at risk Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 participants at risk FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 participants at risk FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Blood and lymphatic system disorders Lymphadenopathy	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Blood and lymphatic system disorders Methaemoglobinaemia	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Blood and lymphatic system disorders Anaemia	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Blood and lymphatic system disorders Leukocytosis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Blood and lymphatic system disorders Necrotising granulomatous lymphadenitis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Blood and lymphatic system disorders Neutropenia	0.50% 3/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Blood and lymphatic system disorders Pancytopenia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Acute coronary syndrome	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Angina pectoris	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Angina unstable	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Atrioventricular block second degree	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Cardiac arrest	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Cardiac failure congestive	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Cardiac tamponade	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Coronary artery disease	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Myocardial infarction	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Pericardial effusion	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Pericardial haemorrhage	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Pericarditis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Pericarditis constrictive	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Cardiac disorders Tachycardia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Congenital, familial and genetic disorders Arteriovenous malformation	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Ear and labyrinth disorders Vertigo	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Endocrine disorders Thyroid disorder	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Endocrine disorders Thyrotoxic crisis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Eye disorders Eye disorder	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Eye disorders Necrotising retinitis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Abdominal hernia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Abdominal pain	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Abdominal pain upper	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Colitis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Constipation	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Crohn's disease	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Diarrhoea	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Diverticular perforation	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Erosive oesophagitis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Food poisoning	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Gastric ulcer	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Haematemesis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Haematochezia	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Hiatus hernia	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Ileus paralytic	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Intestinal obstruction	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Intestinal perforation	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Mouth ulceration	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Pancreatitis	0.50% 3/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Pancreatitis acute	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Pancreatitis chronic	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Proctalgia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Vomiting	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Chest pain	1.2% 7/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	1.2% 7/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Cyst rupture	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Death	0.50% 3/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Fatigue	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Inflammation	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Influenza like illness	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Non-cardiac chest pain	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Pyrexia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.66% 4/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Ulcer	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Hepatobiliary disorders Cholecystitis	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Hepatobiliary disorders Cholecystitis acute	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Hepatobiliary disorders Cholelithiasis	0.66% 4/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Hepatobiliary disorders Hepatic congestion	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Hepatobiliary disorders Hyperbilirubinaemia	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Immune system disorders Anaphylactic shock	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Immune system disorders Drug hypersensitivity	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Immune system disorders Hypersensitivity	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Immune system disorders Immune reconstitution inflammatory syndrome	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Abscess	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Appendicitis	0.66% 4/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Appendicitis perforated	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Arthritis bacterial	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Arthritis infective	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Atypical pneumonia	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Bacteraemia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Bronchitis	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Bronchopneumonia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Cellulitis	0.99% 6/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.83% 5/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.83% 5/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Cryptococcosis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Cytomegalovirus chorioretinitis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Disseminated cytomegaloviral infection	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Fracture	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Diverticulitis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Ear infection	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Eye infection syphilitic	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Gastroenteritis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Groin abscess	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Hepatitis syphilitic	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Herpes virus infection	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Herpes zoster	0.50% 3/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Lobar pneumonia	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Malaria	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Meningitis aseptic	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Meningitis cryptococcal	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Meningitis viral	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Mycobacterial infection	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Neurosyphilis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Osteomyelitis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Osteomyelitis bacterial	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Pelvic abscess	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Pelvic inflammatory disease	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Pharyngitis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Pneumonia	1.3% 8/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	1.00% 6/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	1.3% 8/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Pneumonia bacterial	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Pneumonia cytomegaloviral	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Pneumonia pneumococcal	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Postoperative wound infection	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Proctitis herpes	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Prostatic abscess	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Pyelonephritis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Pyelonephritis acute	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Secondary syphilis	0.50% 3/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Sepsis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Septic shock	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Sinusitis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Sinusitis bacterial	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Soft tissue infection	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Staphylococcal infection	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Subcutaneous abscess	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Tooth abscess	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Tubo-ovarian abscess	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Gun shot wound	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Viral infection	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Viral myocarditis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Burns third degree	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Head injury	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Hip fracture	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Joint injury	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Laryngeal injury	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Limb injury	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Lower limb fracture	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Multiple fractures	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Multiple injuries	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Overdose	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Road traffic accident	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Seroma	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Splenic rupture	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Thermal burn	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Tibia fracture	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Injury, poisoning and procedural complications Toxicity to various agents	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Alanine aminotransferase increased	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood alkaline phosphatase increased	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood bilirubin increased	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood cholesterol increased	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood creatinine increased	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Chest X-ray abnormal	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Haemoglobin decreased	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Hepatic enzyme increased	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Laboratory test abnormal	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Liver function test abnormal	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Neutrophil count decreased	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Staphylococcus test positive	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Transaminases increased	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Metabolism and nutrition disorders Dehydration	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Metabolism and nutrition disorders Diabetes mellitus	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Metabolism and nutrition disorders Failure to thrive	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Metabolism and nutrition disorders Hyperglycaemia	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Metabolism and nutrition disorders Hypoglycaemia	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Metabolism and nutrition disorders Hypokalaemia	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Musculoskeletal and connective tissue disorders Intervertebral disc space narrowing	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Musculoskeletal and connective tissue disorders Muscular weakness	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Musculoskeletal and connective tissue disorders Osteonecrosis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer stage 0	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma stage IV	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.50% 3/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large cell lung cancer metastatic	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mucoepidermoid carcinoma	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular neoplasm	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Carotid artery aneurysm	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Carpal tunnel syndrome	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Cerebrovascular accident	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Complex partial seizures	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Complicated migraine	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Convulsion	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Embolic stroke	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Grand mal convulsion	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Headache	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Hemiparesis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Migraine	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Status epilepticus	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Syncope	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Transient ischaemic attack	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders VIIth nerve paralysis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Wernicke's encephalopathy	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Pregnancy, puerperium and perinatal conditions Blighted ovum	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Acute psychosis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Affective disorder	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Alcohol abuse	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Bipolar disorder	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Catatonia	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Completed suicide	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Depression	0.99% 6/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.66% 4/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.67% 4/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Drug abuse	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Hallucination, auditory	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Homicidal ideation	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Major depression	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Psychotic disorder	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Schizophrenia, paranoid type	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Substance abuse	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Suicidal ideation	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	1.5% 9/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Suicide attempt	0.66% 4/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	1.2% 7/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	1.00% 6/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Renal and urinary disorders Nephrolithiasis	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Renal and urinary disorders Renal failure	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Renal and urinary disorders Renal failure acute	0.50% 3/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.67% 4/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Renal and urinary disorders Renal tubular necrosis	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Reproductive system and breast disorders Breast enlargement	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Asthma	1.2% 7/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.50% 3/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Cough	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.50% 3/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.67% 4/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Mediastinal mass	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.33% 2/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Skin and subcutaneous tissue disorders Rash	0.33% 2/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Surgical and medical procedures Alcohol detoxification	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Surgical and medical procedures Coronary arterial stent insertion	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Surgical and medical procedures Cyst removal	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Surgical and medical procedures Hip arthroplasty	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Surgical and medical procedures Hospitalisation	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Surgical and medical procedures Knee arthroplasty	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Surgical and medical procedures Mastectomy	0.00% 0/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Surgical and medical procedures Nephrectomy	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Surgical and medical procedures Percutaneous coronary intervention	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Surgical and medical procedures Spinal laminectomy	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Vascular disorders Deep vein thrombosis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Vascular disorders Hypertension	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Vascular disorders Hypertensive crisis	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Vascular disorders Hypotension	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Vascular disorders Orthostatic hypotension	0.17% 1/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0

Other adverse events

Measure	Arm A: ATV/RTV + FTC/TDF n=605 participants at risk Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	Arm B: RAL + FTC/TDF n=603 participants at risk FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	Arm C: DRV/RTV + FTC/TDF n=601 participants at risk FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
Eye disorders Ocular icterus	6.6% 40/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.17% 1/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	0.00% 0/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Abdominal pain	5.8% 35/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	3.8% 23/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	5.3% 32/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Anogenital dysplasia	5.1% 31/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	4.1% 25/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	3.8% 23/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Diarrhoea	10.1% 61/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	7.5% 45/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	11.1% 67/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Nausea	10.1% 61/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	7.1% 43/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	9.8% 59/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Gastrointestinal disorders Vomiting	6.9% 42/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	4.8% 29/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	6.7% 40/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Fatigue	6.8% 41/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	6.0% 36/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	5.8% 35/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
General disorders Pyrexia	6.1% 37/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	6.5% 39/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	6.2% 37/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Bronchitis	4.6% 28/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	5.5% 33/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	4.7% 28/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Infections and infestations Upper respiratory tract infection	6.0% 36/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	4.6% 28/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	4.8% 29/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Alanine aminotransferase increased	11.2% 68/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	9.8% 59/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	7.7% 46/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Aspartate aminotransferase increased	12.1% 73/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	12.8% 77/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	11.5% 69/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood bilirubin increased	52.6% 318/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	3.3% 20/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	2.0% 12/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood cholesterol increased	35.0% 212/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	25.2% 152/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	37.8% 227/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood creatinine increased	17.4% 105/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	12.1% 73/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	16.3% 98/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood glucose decreased	10.7% 65/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	14.8% 89/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	13.6% 82/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood glucose increased	19.0% 115/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	15.8% 95/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	17.5% 105/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood phosphorus decreased	11.6% 70/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	11.1% 67/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	11.6% 70/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Blood sodium decreased	9.4% 57/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	10.8% 65/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	9.2% 55/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Low density lipoprotein increased	30.4% 184/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	23.1% 139/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	30.4% 183/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Neutrophil count decreased	12.2% 74/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	14.1% 85/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	12.3% 74/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations Platelet count decreased	4.1% 25/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	5.3% 32/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	4.0% 24/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Investigations White blood cell count decreased	5.6% 34/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	5.8% 35/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	5.3% 32/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 29/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	4.8% 29/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	5.3% 32/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Musculoskeletal and connective tissue disorders Back pain	4.1% 25/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	5.5% 33/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	3.8% 23/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Musculoskeletal and connective tissue disorders Pain in extremity	8.1% 49/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	8.1% 49/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	5.8% 35/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Nervous system disorders Headache	7.4% 45/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	8.0% 48/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	7.7% 46/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Psychiatric disorders Depression	7.8% 47/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	10.0% 60/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	8.8% 53/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Cough	8.9% 54/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	8.8% 53/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	7.7% 46/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.8% 29/605 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	5.3% 32/603 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0	3.7% 22/601 • From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), dated May 6, 2004. MedDRA version 17.0

Additional Information

ACTG Clinicaltrials.gov Coordinator

ACTG Network Coordinating Center, Social & Scientific Systems, Inc.

Phone: (301) 628-3313

Email: ACTGCT.Gov@s-3.com

Results disclosure agreements

• Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER