Trial Outcomes & Findings for Strategic Timing of Antiretroviral Treatment (NCT NCT00867048)

NCT ID: NCT00867048

Last Updated: 2024-03-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 4688 participants
• Primary outcome timeframe: full follow-up, 9.3 years
• Results posted on: 2024-03-04

Participant Flow

Participant milestones

Measure	Early ART Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.	Deferred ART Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
Overall Study STARTED	2326	2362
Overall Study COMPLETED	2325	2359
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Strategic Timing of Antiretroviral Treatment

Baseline characteristics by cohort

Measure	Early ART n=2326 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=2362 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Total n=4688 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2308 Participants n=5 Participants	2345 Participants n=7 Participants	4653 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Age, Continuous	36.8 years STANDARD_DEVIATION 10.2 • n=5 Participants	36.8 years STANDARD_DEVIATION 10.1 • n=7 Participants	36.8 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	624 Participants n=5 Participants	635 Participants n=7 Participants	1259 Participants n=5 Participants
Sex: Female, Male Male	1702 Participants n=5 Participants	1727 Participants n=7 Participants	3429 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	197 Participants n=5 Participants	190 Participants n=7 Participants	387 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	701 Participants n=5 Participants	704 Participants n=7 Participants	1405 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1025 Participants n=5 Participants	1084 Participants n=7 Participants	2109 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	308 Participants n=5 Participants	303 Participants n=7 Participants	611 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	91 Participants n=5 Participants	74 Participants n=7 Participants	165 Participants n=5 Participants

PRIMARY outcome

Timeframe: full follow-up, 9.3 years

Outcome measures

Measure	Early ART n=2325 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=2359 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality	133 Participants	215 Participants

SECONDARY outcome

Timeframe: full follow-up, 9.3 years

participant count

Outcome measures

Measure	Early ART n=2325 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=2359 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
AIDs or AIDs Related Death	31 Participants	83 Participants

SECONDARY outcome

Timeframe: full follow-up, 9.3 years

Outcome measures

Measure	Early ART n=2325 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=2359 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Specific Non-AIDS Diagnoses	107 Participants	137 Participants

SECONDARY outcome

Timeframe: full follow-up, 9.3 years

Count of participants

Outcome measures

Measure	Early ART n=2325 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=2359 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Death, All-cause Mortality	66 Participants	85 Participants

SECONDARY outcome

Timeframe: 4.5 years

Mean change from baseline of the VAS. This was a single data item where participants self-reported their perceived current state of health on a scale of 0-100 (0=worst possible and 100=best possible).

Outcome measures

Measure	Early ART n=2253 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=2287 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health	1.8 units on a scale Standard Deviation 8.6	0.22 units on a scale Standard Deviation 8.7

SECONDARY outcome

Timeframe: 12 months

Proportion of participants identifying as men who have sex with men (MSM) engaging in condomless sex with HIV serodifferent partners (CLS-D) at study month 12. Participant completed a self-reported questionnaire on transmission risk behavior during the "past two months" at the month 12 visit following randomization.

Outcome measures

Measure	Early ART n=1236 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=1187 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Transmission Risk Behavior Outcome 1	156 Participants	155 Participants

SECONDARY outcome

Timeframe: 4.5 years

Mean change from baseline of the QNPZ-8 score. In the Neurology substudy of START, participants were administered a neuropsychological test battery of 8 tests (grooved peg board, finger tapping, Color Trails 1 and 2, Semantic Verbal Fluency, WAIS III Digit Symbol, HVLT-R Learning, HVLT-R Delayed Recall). Test scores were standardized to z-scores using baseline values as reference such that baseline values had a mean of 0 and standard deviation of 1. Test scores were standardized to z-scores using baseline values as reference such that baseline values had a mean of 0 and standard deviation of 1. Z-scores > 0 indicate improvement over baseline levels. The quantitative neuropsychological performance z-score (QNPZ-8) was the mean of the z-scores across the the 8 tests. Analyses were by intention-to-treat principles.

Outcome measures

Measure	Early ART n=291 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=301 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Change in Neurocognitive Function (in a Subset of Participants)	0.19 units on a scale Interval 0.16 to 0.23	0.21 units on a scale Interval 0.18 to 0.25

SECONDARY outcome

Timeframe: 4.5 years

Mean change from baseline in large arterial elasticity. In the Arterial Elasticity substudy of START, participants had non-invasive measurements of radial artery blood pressure waveforms recorded at baseline, study months 4, 8, and 12, and then annually. Small arterial elasticity (SAE) and large arterial elasticity (LAE) were derived from analysis of the diastolic pulse waveform. Analyses were by intention-to-treat principles.

Outcome measures

Measure	Early ART n=178 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=154 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Large Artery Elasticity (in a Subset of Participants)	0.27 mL/mmHg x 10 Interval 0.02 to 0.53	0.8 mL/mmHg x 10 Interval 0.52 to 1.07

SECONDARY outcome

Timeframe: 4.5 years

Rate of lung function decline (slope of forced expiratory volume (FEV1)) over follow-up among self-reported smokers at study entry. In the pulmonary substudy of START, participants had post-bronchodilator spirometry measures collected at baseline and annually. Analyses were by intention-to-treat principles.

Outcome measures

Measure	Early ART n=135 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=156 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Rate of Lung Function Decline (in a Subset of Participants) Among	-36.6 mL/yr Interval -51.0 to -22.3	-38.8 mL/yr Interval -52.8 to -24.8

SECONDARY outcome

Timeframe: 4.5 years

Mean percent change from baseline in bone mineral density at the spine. In the bone mineral density (BMD) substudy of START, participants underwent dual-enery x-ray absorptionmetry (DXA) to measure BMD at the spine and hip at baseline and annually. Analyses were by intention-to-treat principles.

Outcome measures

Measure	Early ART n=201 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=210 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Changes in Bone Mineral Density (in a Subset of Participants) Measure 1	-1.8 percent Interval -2.3 to -1.4	-0.9 percent Interval -1.3 to -0.4

SECONDARY outcome

Timeframe: 12 month visit

Percentage of participants identifying as hetrosexual engaging in condomless sex with HIV serodifferent partners (CLS-D) at study month 12. Participant completed a self-reported questionnaire on transmission risk behavior during the "past two months" at the month 12 visit following randomization.

Outcome measures

Measure	Early ART n=934 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=964 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Transmission Risk Behavior Outcome 2	101 Participants	80 Participants

SECONDARY outcome

Timeframe: 4.5 years

Mean change from baseline in small arterial elasticity. In the Arterial Elasticity substudy of START, participants had non-invasive measurements of radial artery blood pressure waveforms recorded at baseline, study months 4, 8, and 12, and then annually. Small arterial elasticity (SAE) and large arterial elasticity (LAE) were derived from analysis of the diastolic pulse waveform. Analyses were by intention-to-treat principles.

Outcome measures

Measure	Early ART n=178 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=154 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Small Artery Elasticity (in a Subset of Participants)	-0.23 mL/mmHg x 10 Interval -0.41 to -0.06	-0.18 mL/mmHg x 10 Interval -0.37 to 0.01

SECONDARY outcome

Timeframe: 4.5 years

Rate of lung function decline (slope of forced expiratory volume (FEV1)) over follow-up among self-reported non-smokers at study entry. In the pulmonary substudy of START, participants had post-bronchodilator spirometry measures collected at baseline and annually. Analyses were by intention-to-treat principles.

Outcome measures

Measure	Early ART n=383 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=353 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Rate of Lung Function Decline (in a Subset of Participants) Among Non-smokers	-26.9 mL/yr Interval -34.1 to -19.8	-22.8 mL/yr Interval -30.4 to -15.3

SECONDARY outcome

Timeframe: 4.5 years

Mean percent change from baseline in bone mineral density at the spine. In the bone mineral density (BMD) substudy of START, participants underwent dual-enery x-ray absorptionmetry (DXA) to measure BMD at the spine and hip at baseline and annually. Analyses were by intention-to-treat principles.

Outcome measures

Measure	Early ART n=200 Participants Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=210 Participants Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Changes in Bone Mineral Density (in a Subset of Participants) Measure 2	-2.8 percent Interval -3.3 to -2.2	-1.7 percent Interval -2.2 to -1.1

Adverse Events

Early ART

Serious events: 428 serious events

Other events: 0 other events

Deaths: 66 deaths

Deferred ART

Serious events: 500 serious events

Other events: 0 other events

Deaths: 85 deaths

Serious adverse events

Measure	Early ART n=2325 participants at risk Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	Deferred ART n=2359 participants at risk Defer ART until the CD4+ count declines to \<350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Blood and lymphatic system disorders Anaemia	0.22% 5/2325 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.30% 7/2359 • Number of events 7 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Blood and lymphatic system disorders Febrile neutropenia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Blood and lymphatic system disorders Lymphadenopathy	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Blood and lymphatic system disorders Pancytopenia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Acute coronary syndrome	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Acute myocardial infarction	0.34% 8/2325 • Number of events 8 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.25% 6/2359 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Angina pectoris	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Angina unstable	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Aortic valve stenosis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Arrhythmia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Atrial fibrillation	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Atrial flutter	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Cardiac failure	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Cardiac failure acute	0.04% 1/2325 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Cardiac failure congestive	0.04% 1/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Cardiomyopathy	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Coronary artery disease	0.09% 2/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Foetal arrhythmia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Mitral valve incompetence	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Myocardial infarction	0.22% 5/2325 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Palpitations	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Silent myocardial infarction	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Sinus tachycardia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Subvalvular aortic stenosis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Supraventricular tachycardia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Cardiac disorders Ventricular tachycardia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Congenital, familial and genetic disorders Alagille syndrome	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Congenital, familial and genetic disorders Anencephaly	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Congenital, familial and genetic disorders Congenital hydrocephalus	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Congenital, familial and genetic disorders Congenital hydronephrosis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Congenital, familial and genetic disorders Microcephaly	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Congenital, familial and genetic disorders Patent ductus arteriosus	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Congenital, familial and genetic disorders Ventricular septal defect	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Ear and labyrinth disorders Tinnitus	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Ear and labyrinth disorders Vertigo	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Ear and labyrinth disorders Vertigo positional	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Eye disorders Disorder of orbit	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Eye disorders Opsoclonus myoclonus	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Eye disorders Retinal artery occlusion	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Eye disorders Vision blurred	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Abdominal hernia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Abdominal pain	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Abdominal pain upper	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Abdominal strangulated hernia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Acute abdomen	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Alcoholic pancreatitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Anal fissure	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Anal haemorrhage	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Anal pruritus	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Anogenital dysplasia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Colitis	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Colitis ulcerative	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Diarrhoea	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Dysphagia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Enteritis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Faecaloma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Food poisoning	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Functional gastrointestinal disorder	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Gastric disorder	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Gastritis	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Gastrointestinal toxicity	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Hiatus hernia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Ileus	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Inflammatory bowel disease	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Inguinal hernia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Inguinal hernia, obstructive	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Intestinal obstruction	0.17% 4/2325 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Intra-abdominal fluid collection	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Large intestine perforation	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Mallory-Weiss syndrome	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Megacolon	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Obstruction gastric	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Odynophagia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Oesophageal rupture	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Pancreatitis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Pancreatitis acute	0.04% 1/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Proctitis	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.21% 5/2359 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Rectal haemorrhage	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Rectal perforation	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Small intestinal obstruction	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Strangulated umbilical hernia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Tooth impacted	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Umbilical hernia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Gastrointestinal disorders Vomiting	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Chest pain	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Chills	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Complication of device insertion	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Death	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.51% 12/2359 • Number of events 12 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Drowning	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Drug withdrawal syndrome	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Fatigue	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Gait disturbance	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Impaired self-care	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Influenza like illness	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Multiple organ dysfunction syndrome	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Necrobiosis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Non-cardiac chest pain	0.09% 2/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Peripheral swelling	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Pyrexia	0.34% 8/2325 • Number of events 8 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.47% 11/2359 • Number of events 12 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Strangulated hernia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
General disorders Systemic inflammatory response syndrome	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Autoimmune hepatitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Biliary colic	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Cholangitis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Cholecystitis	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Cholecystitis acute	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.21% 5/2359 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Cholelithiasis	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Cholelithiasis migration	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Drug-induced liver injury	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Hepatic failure	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Hepatitis	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Hepatitis acute	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Hyperbilirubinaemia	0.13% 3/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Hepatobiliary disorders Liver disorder	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Immune system disorders Anaphylactic shock	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Immune system disorders Drug hypersensitivity	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Immune system disorders Hypersensitivity	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Immune system disorders Sarcoidosis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Abdominal abscess	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Abdominal infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Abscess	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Abscess limb	0.30% 7/2325 • Number of events 7 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Abscess neck	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Acute hepatitis B	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Acute hepatitis C	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Anal abscess	0.22% 5/2325 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.55% 13/2359 • Number of events 14 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Appendicitis	1.0% 24/2325 • Number of events 24 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.72% 17/2359 • Number of events 17 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Appendicitis perforated	0.04% 1/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Arteriovenous graft site abscess	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Arthritis bacterial	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Bacteraemia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Bacterial diarrhoea	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Bacterial pyelonephritis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Bronchitis	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Bronchitis viral	0.04% 1/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Burn infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Campylobacter gastroenteritis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Campylobacter sepsis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Catheter site infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Cellulitis	0.22% 5/2325 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.42% 10/2359 • Number of events 12 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Cellulitis staphylococcal	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Complicated appendicitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Cryptosporidiosis infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Dengue fever	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Dengue haemorrhagic fever	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Device related infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Diabetic foot infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Diarrhoea infectious	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Diverticulitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Diverticulitis intestinal haemorrhagic	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Dysentery	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Embolic pneumonia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Endocarditis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Endocarditis bacterial	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Epididymitis	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Epiglottic abscess	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Erysipelas	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Escherichia pyelonephritis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Escherichia urinary tract infection	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Extradural abscess	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Febrile infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Fournier's gangrene	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Furuncle	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Gastroenteritis	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.42% 10/2359 • Number of events 10 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Gastroenteritis bacterial	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Gastroenteritis cryptosporidial	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Gastroenteritis salmonella	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Gastroenteritis shigella	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Gastroenteritis viral	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Gastrointestinal infection	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Genital herpes simplex	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Giardiasis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Gonorrhoea	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Groin abscess	0.09% 2/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations HIV associated nephropathy	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations HIV peripheral neuropathy	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Hepatitis A	0.26% 6/2325 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Hepatitis C	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Herpes simplex necrotising retinopathy	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Herpes zoster	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Infected skin ulcer	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Influenza	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.30% 7/2359 • Number of events 7 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Intervertebral discitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Large intestine infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Liver abscess	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Localised infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Lower respiratory tract infection	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Lymph node abscess	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Lymphogranuloma venereum	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Malaria	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.38% 9/2359 • Number of events 10 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Meningitis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Meningitis streptococcal	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Meningitis viral	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Meningoencephalitis herpetic	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Mononucleosis syndrome	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Mycobacterium abscessus infection	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Necrotising fasciitis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Neurosyphilis	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.25% 6/2359 • Number of events 7 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Neutropenic sepsis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Orchitis	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Osteomyelitis	0.04% 1/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Osteomyelitis chronic	0.04% 1/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Otitis media acute	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Paronychia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Parotid abscess	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Parotitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pelvic inflammatory disease	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Perirectal abscess	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Peritonitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Peritonsillar abscess	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pertussis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pharyngitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pharyngotonsillitis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pilonidal disease	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pneumococcal bacteraemia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pneumonia	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pneumonia aspiration	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Postoperative wound infection	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Proctitis chlamydial	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pyelonephritis	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pyelonephritis acute	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Pyomyositis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Rectal abscess	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Renal abscess	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Rubella	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Scrotal abscess	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Secondary syphilis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Sepsis	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.25% 6/2359 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Sepsis syndrome	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Septic shock	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Shigella infection	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Soft tissue infection	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Staphylococcal abscess	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Staphylococcal sepsis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Staphylococcal skin infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Streptococcal bacteraemia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Streptococcal sepsis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Strongyloidiasis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Subcutaneous abscess	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Syphilis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Tertiary syphilis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Tonsillitis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Tonsillitis streptococcal	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Tooth abscess	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Tuberculosis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Tubo-ovarian abscess	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Typhoid fever	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Upper respiratory tract infection	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Urinary tract infection	0.22% 5/2325 • Number of events 7 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Urosepsis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Varicella	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Viral infection	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Viral pharyngitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Viral upper respiratory tract infection	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Wound infection	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Wound infection staphylococcal	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Infections and infestations Wound sepsis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Accidental overdose	0.13% 3/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Accidental poisoning	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Alcohol poisoning	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Ankle fracture	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Back injury	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Contusion	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Craniocerebral injury	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Eye injury	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Fall	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Femoral neck fracture	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Femur fracture	0.04% 1/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Foot fracture	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Forearm fracture	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Fracture of penis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Gastrointestinal procedural complication	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Gun shot wound	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Hand fracture	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Head injury	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.21% 5/2359 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Humerus fracture	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Injury	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Intentional overdose	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Joint injury	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Limb injury	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Lower limb fracture	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Meniscus injury	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Multiple fractures	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Multiple injuries	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Nasal injury	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Patella fracture	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Post concussion syndrome	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Post lumbar puncture syndrome	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Post procedural haematoma	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Post procedural haematuria	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Procedural complication	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Radius fracture	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Reactive gastropathy	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Rib fracture	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Scrotal haematoma	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Soft tissue injury	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Stab wound	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Subdural haematoma	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Tendon rupture	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Testicular injury	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Thermal burn	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Tibia fracture	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Toxicity to various agents	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Traumatic haemothorax	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Upper limb fracture	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Vascular graft occlusion	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Wound dehiscence	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Injury, poisoning and procedural complications Wrist fracture	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Investigations Blood glucose increased	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Metabolism and nutrition disorders Dehydration	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Metabolism and nutrition disorders Gout	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Metabolism and nutrition disorders Hyperglycaemia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Arthralgia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Arthritis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Back pain	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 12 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Muscle spasms	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Polyarthritis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Musculoskeletal and connective tissue disorders Synovitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal squamous cell carcinoma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign hydatidiform mole	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's lymphoma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Castleman's disease	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extragonadal primary seminoma (pure)	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrosarcoma	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloid leukaemia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurilemmoma benign	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.04% 1/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seminoma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.04% 1/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular germ cell cancer	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell cancer of the renal pelvis and ureter	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma metastatic	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Aphasia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Arachnoid cyst	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Bell's palsy	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Cauda equina syndrome	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Central nervous system lesion	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Cerebral haemorrhage	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Cerebrovascular accident	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.21% 5/2359 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Cognitive disorder	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Demyelination	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Dizziness	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Drug withdrawal convulsions	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Encephalopathy	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Epilepsy	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Facial paresis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Generalised tonic-clonic seizure	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Haemorrhage intracranial	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Haemorrhagic transformation stroke	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Headache	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Hepatic encephalopathy	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Hydrocephalus	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Idiopathic intracranial hypertension	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Intracranial mass	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Metabolic encephalopathy	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Migraine	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Neuropathy peripheral	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Paraesthesia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Partial seizures	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Petit mal epilepsy	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Polyneuropathy	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Postictal state	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Seizure	0.09% 2/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Spinal cord compression	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Syncope	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders Transient ischaemic attack	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Nervous system disorders VIth nerve paralysis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Cephalo-pelvic disproportion	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.17% 4/2325 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Foetal death	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	0.17% 4/2325 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.21% 5/2359 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Premature delivery	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Premature labour	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Prolonged labour	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Ruptured ectopic pregnancy	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Pregnancy, puerperium and perinatal conditions Umbilical cord prolapse	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Acute psychosis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Acute stress disorder	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Affective disorder	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Agitation	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Alcohol abuse	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Alcohol withdrawal syndrome	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Alcoholism	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Anxiety	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Bipolar I disorder	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Bipolar disorder	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Burnout syndrome	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Cardiovascular somatic symptom disorder	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Completed suicide	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.21% 5/2359 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Conversion disorder	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Delirium	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Depression	0.34% 8/2325 • Number of events 9 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.55% 13/2359 • Number of events 18 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Depression suicidal	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Drug abuse	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Drug dependence	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Hallucination	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Hallucination, auditory	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Homicidal ideation	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Intentional self-injury	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Major depression	0.30% 7/2325 • Number of events 8 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Mental disorder	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Panic attack	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Persecutory delusion	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Psychiatric decompensation	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Psychotic disorder	0.09% 2/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Schizoaffective disorder	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Schizophrenia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Self-injurious ideation	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Substance abuse	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Substance-induced mood disorder	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Substance-induced psychotic disorder	0.13% 3/2325 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Suicidal ideation	0.60% 14/2325 • Number of events 22 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.68% 16/2359 • Number of events 22 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Psychiatric disorders Suicide attempt	1.0% 24/2325 • Number of events 34 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.85% 20/2359 • Number of events 22 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Acute kidney injury	0.47% 11/2325 • Number of events 11 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.25% 6/2359 • Number of events 6 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Anuria	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Calculus urinary	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Diabetic nephropathy	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders End stage renal disease	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Glomerulonephritis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Nephrolithiasis	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.17% 4/2359 • Number of events 4 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Nephropathy	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Renal colic	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Renal failure	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Ureterolithiasis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Urethral stenosis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Urinary retention	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Abnormal uterine bleeding	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Cystocele	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Genital rash	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Ovarian cyst	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Priapism	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Prostatitis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Testicular pain	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Testicular torsion	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Uterine adhesions	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Asthma	0.17% 4/2325 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.21% 5/2359 • Number of events 8 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.13% 3/2325 • Number of events 3 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.21% 5/2359 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Respiratory, thoracic and mediastinal disorders Tracheomalacia	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Skin and subcutaneous tissue disorders Dermal cyst	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Skin and subcutaneous tissue disorders Xanthoma	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Social circumstances Homicide	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Social circumstances Substance use	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Surgical and medical procedures Appendicectomy	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.08% 2/2359 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Vascular disorders Aortic aneurysm	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Vascular disorders Aortitis	0.00% 0/2325 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Vascular disorders Deep vein thrombosis	0.22% 5/2325 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.13% 3/2359 • Number of events 5 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Vascular disorders Hypertension	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Vascular disorders Hypertensive crisis	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Vascular disorders Peripheral arterial occlusive disease	0.09% 2/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.04% 1/2359 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Vascular disorders Peripheral artery thrombosis	0.04% 1/2325 • Number of events 2 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Vascular disorders Peripheral ischaemia	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.
Vascular disorders Vena cava thrombosis	0.04% 1/2325 • Number of events 1 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.	0.00% 0/2359 • All-Cause Mortality assessed up to a median of 9.3 years. Serious Adverse Events were assessed for a median of 5.5 years Non-serious adverse events were not collected. Of the total number of participants randomized, 4 participants were found out to be HIV negative. Those participants were all administratively withdrawn from the study and were not followed for adverse events. Adverse events reported are those collected as "Serious Events" which were only collected through 31 December 2017. Deaths were collected through full follow-up and are reported separately under Outcome 4.

Other adverse events

Adverse event data not reported

Additional Information

Birgit Grund

University of Minnesota

Phone: 612-624-8076

Email: birgit@umn.edu

Results disclosure agreements

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