Trial Outcomes & Findings for Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults (NCT NCT03739866)

Last Updated: 2021-04-09

Results Overview

Maximum reduction is defined as the minimum of change from baseline in plasma HIV-1 RNA (i.e. smallest change in HIV-RNA from baseline).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

53 participants

Primary outcome timeframe

Day 1 through Day 10

Results posted on

2021-04-09

Participant Flow

Participants were enrolled at study sites in the United States. The first participant was screened on 26 November 2018. The last study visit occurred on 15 June 2020.

89 participants were screened.

Participant milestones

Participant milestones
Measure	Part A: Lenacapavir 20 mg Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: Tenofovir Alafenamide (TAF) 200 mg Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Overall Study STARTED	6	6	7	6	6	10	7	5
Overall Study COMPLETED	6	6	6	5	5	10	7	5
Overall Study NOT COMPLETED	0	0	1	1	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Lenacapavir 20 mg Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: Tenofovir Alafenamide (TAF) 200 mg Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Overall Study Lost to Follow-up	0	0	0	1	0	0	0	0
Overall Study Enrolled but not treated	0	0	1	0	1	0	0	0

Baseline Characteristics

Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 Participants Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 Participants Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=5 Participants Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=10 Participants Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 200 mg n=7 Participants Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg n=5 Participants Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy on started on Day 10 through Day 225.	Total n=51 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 4.4 • n=5 Participants	36 years STANDARD_DEVIATION 14.4 • n=7 Participants	39 years STANDARD_DEVIATION 11.5 • n=5 Participants	36 years STANDARD_DEVIATION 15.5 • n=4 Participants	37 years STANDARD_DEVIATION 17.7 • n=21 Participants	29 years STANDARD_DEVIATION 9.3 • n=8 Participants	29 years STANDARD_DEVIATION 8.7 • n=8 Participants	40 years STANDARD_DEVIATION 8.7 • n=24 Participants	34 years STANDARD_DEVIATION 11.5 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=8 Participants	7 Participants n=8 Participants	5 Participants n=24 Participants	47 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants	2 Participants n=24 Participants	13 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	9 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	38 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Race · Black	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	13 Participants n=42 Participants
Race/Ethnicity, Customized Race · White	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	5 Participants n=8 Participants	5 Participants n=24 Participants	31 Participants n=42 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
HIV-1 RNA	4.46 log10 copies/mL STANDARD_DEVIATION 0.428 • n=5 Participants	4.44 log10 copies/mL STANDARD_DEVIATION 0.328 • n=7 Participants	4.48 log10 copies/mL STANDARD_DEVIATION 0.161 • n=5 Participants	4.52 log10 copies/mL STANDARD_DEVIATION 0.190 • n=4 Participants	4.56 log10 copies/mL STANDARD_DEVIATION 0.305 • n=21 Participants	4.50 log10 copies/mL STANDARD_DEVIATION 0.371 • n=8 Participants	4.23 log10 copies/mL STANDARD_DEVIATION 0.621 • n=8 Participants	4.97 log10 copies/mL STANDARD_DEVIATION 0.439 • n=24 Participants	4.50 log10 copies/mL STANDARD_DEVIATION 0.403 • n=42 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 10

Population: The Full Analysis Set (FAS) included all participants who were randomized/enrolled and received at least 1 full dose of study drug.

Maximum reduction is defined as the minimum of change from baseline in plasma HIV-1 RNA (i.e. smallest change in HIV-RNA from baseline).

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg n=7 Participants Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 Participants Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 Participants Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=5 Participants Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=10 Participants Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg n=5 Participants Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part A and Part B: Maximum Reduction From Day 1 (Baseline) Through Day 10 in Plasma HIV-1 RNA	-0.75 log10 copies/mL Standard Deviation 0.270	-1.35 log10 copies/mL Standard Deviation 0.318	-1.79 log10 copies/mL Standard Deviation 0.476	-1.76 log10 copies/mL Standard Deviation 0.203	-2.20 log10 copies/mL Standard Deviation 0.468	-2.26 log10 copies/mL Standard Deviation 0.662	-0.17 log10 copies/mL Standard Deviation 0.128	-0.91 log10 copies/mL Standard Deviation 0.294

SECONDARY outcome

Timeframe: Day 1 through 225 days

Population: The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as any AE with an onset date on or after the study drug start date.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg n=7 Participants Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 Participants Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 Participants Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=5 Participants Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=10 Participants Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg n=5 Participants Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)	85.7 percentage of participants	83.3 percentage of participants	100 percentage of participants	83.3 percentage of participants	100 percentage of participants	80 percentage of participants	70 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Day 1 through 225 days

Population: Participants in the Safety Analysis Set were analyzed.

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg n=7 Participants Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 Participants Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 Participants Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=5 Participants Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=10 Participants Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg n=5 Participants Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities	100.0 percentage of participants	83.3 percentage of participants	83.3 percentage of participants	100.0 percentage of participants	66.7 percentage of participants	100.0 percentage of participants	80.0 percentage of participants	80.0 percentage of participants

SECONDARY outcome

Timeframe: Part A: 0 (predose),1,2,4,8,12,24 h postdose on Day 1, anytime on Days 3,4,7,8,9,10,14,29,43,57,85,113,141,169,197,225; Part B: 0 (predose),0.5,1,2,3,4,6,8,10,12,24 and 48 h postdose on Day 1, approximately Day 1 predose time on Days 4,5,6,7,8,9,10

Population: Participants in the PK Analysis Set were analyzed.

AUCinf is defined as area under the concentration versus time curve from time zero to infinity.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg n=5 Participants Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 Participants Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 Participants Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=5 Participants Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=7 Participants Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part A and Part B Pharmacokinetic (PK) Parameter: AUCinf of Lenacapavir, TAF and Its Metabolite TFV Part A: Lenacapavir	—	6564.3 h*ng/mL Standard Deviation 2562.02	9124.1 h*ng/mL Standard Deviation 4443.03	31537.0 h*ng/mL Standard Deviation 6811.74	106041.1 h*ng/mL Standard Deviation 19939.41	181861.0 h*ng/mL Standard Deviation 73100.91	—	—
Part A and Part B Pharmacokinetic (PK) Parameter: AUCinf of Lenacapavir, TAF and Its Metabolite TFV Part B: TAF	3556.1 h*ng/mL Standard Deviation 1396.81	—	—	—	—	—	1270.3 h*ng/mL Standard Deviation 346.47	—
Part A and Part B Pharmacokinetic (PK) Parameter: AUCinf of Lenacapavir, TAF and Its Metabolite TFV Part B: TFV	13435.4 h*ng/mL Standard Deviation 1748.60	—	—	—	—	—	2807.9 h*ng/mL Standard Deviation 904.23	—

SECONDARY outcome

Population: Participants in the PK Analysis Set were analyzed.

AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg n=5 Participants Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 Participants Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 Participants Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=5 Participants Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=7 Participants Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part A and Part B PK Parameter: AUClast of Lenacapavir, TAF and Its Metabolite TFV Part A: Lenacapavir	—	5084.3 h*ng/mL Standard Error 2143.03	7524.4 h*ng/mL Standard Error 4140.40	28866.4 h*ng/mL Standard Error 8247.37	102919.0 h*ng/mL Standard Error 19984.50	171173.9 h*ng/mL Standard Error 80524.85	—	—
Part A and Part B PK Parameter: AUClast of Lenacapavir, TAF and Its Metabolite TFV Part B: TAF	3553.0 h*ng/mL Standard Error 1396.14	—	—	—	—	—	1265.8 h*ng/mL Standard Error 350.75	—
Part A and Part B PK Parameter: AUClast of Lenacapavir, TAF and Its Metabolite TFV Part B: TFV	12682.5 h*ng/mL Standard Error 1780.31	—	—	—	—	—	2706.7 h*ng/mL Standard Error 877.05	—

SECONDARY outcome

Population: Participants in the PK Analysis Set were analyzed.

Cmax is defined as the maximum observed concentration of drug.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg n=5 Participants Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 Participants Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 Participants Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=5 Participants Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=7 Participants Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part A and Part B PK Parameter: Cmax of Lenacapavir, TAF and Its Metabolite TFV Part A: Lenacapavir	—	3.0 ng/mL Standard Deviation 1.00	5.4 ng/mL Standard Deviation 4.00	17.1 ng/mL Standard Deviation 7.33	60.1 ng/mL Standard Deviation 16.92	116.6 ng/mL Standard Deviation 40.38	—	—
Part A and Part B PK Parameter: Cmax of Lenacapavir, TAF and Its Metabolite TFV Part B: TAF	3934.0 ng/mL Standard Deviation 742.85	—	—	—	—	—	1919.0 ng/mL Standard Deviation 822.57	—
Part A and Part B PK Parameter: Cmax of Lenacapavir, TAF and Its Metabolite TFV Part B: TFV	371.0 ng/mL Standard Deviation 72.76	—	—	—	—	—	93.0 ng/mL Standard Deviation 36.97	—

SECONDARY outcome

Timeframe: Part B: 0 (predose), 1, 2, 4, 6, 8, 12, 24 and 48 hours post dose on Day 1, approximately Day 1 predose time on Days 4, 5 (if possible), 6 (if possible), 7, 8, 9, 10

Population: The peripheral blood mononuclear cell (PBMC) PK Analysis Set included all participants who are enrolled in Part B of the study, received at least 1 dose of study drug, and had at least 1 nonmissing TFV-DP concentration. Participants with available data were analyzed.

AUCinf is defined as area under the concentration versus time curve from time zero to infinity.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=4 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=5 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part B PK Parameter: AUCinf of TFV-DP Metabolite of TAF	—	599.7 h*uM Standard Deviation 299.36	7981.4 h*uM Standard Deviation 3852.75	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B: 0 (predose), 1, 2, 4, 6, 8, 12, 24 and 48 hours post dose on Day 1, approximately Day 1 predose time on Days 4, 5 (if possible), 6 (if possible), 7, 8, 9, 10

Population: Participants in the PBMC PK Analysis Set with available data were analyzed.

AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=5 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part B PK Parameter: AUClast of TFV-DP Metabolite of TAF	—	390.9 h*uM Standard Deviation 372.31	7749.3 h*uM Standard Deviation 3731.57	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B: 0 (predose), 1, 2, 4, 6, 8, 12, 24 and 48 hours post dose on Day 1, approximately Day 1 predose time on Days 4, 5 (if possible), 6 (if possible), 7, 8, 9, 10

Population: Participants in the PBMC PK Analysis Set with available data were analyzed.

Cmax is defined as the maximum observed concentration of drug.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=5 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part B PK Parameter: Cmax of TFV-DP Metabolite of TAF	—	8.5 uM Standard Deviation 9.94	163.0 uM Standard Deviation 118.75	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 10

Population: Participants in the FAS Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 Participants Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 Participants Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=5 Participants Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=10 Participants Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part A: Percentage of Participants Ever Achieving HIV-1 RNA < 50 Copies/mL by Day 10	—	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	16.7 percentage of participants	20.0 percentage of participants	0 percentage of participants	—

SECONDARY outcome

Timeframe: Day 10

Population: Participants in the End of Monotherapy Resistance Analysis Population who had received 1 dose of study drug or placebo, regardless of virologic status were analyzed. One participant in 'Part A: Lenacapavir 750 mg' group had assay failure and thus was not included in the analysis.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 Participants Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 Participants Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=4 Participants Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=10 Participants Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part A: Number of Participants Experiencing Any Emergence of Capsid Inhibitor Resistance	—	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Day 10 through Day 225

Population: Participants in the Post-Monotherapy Resistance Analysis Population were analyzed.

Post-Monotherapy Resistance Analysis Population analyzed for this outcome measure included any participant who received at least 1 dose of study drug/placebo, maintained their study drug regimen, \& met one of following virologic failure criteria: * HIV-1 RNA ≥ 50 copies/mL \& \< 1 log10 HIV-1 RNA reduction from Day 10 at Day 57 visit, confirmed at a scheduled or unscheduled visit at least 2 weeks following Day 57 * At any visit following Day 10, after achieving HIV-1 RNA \< 50 copies/mL, a rebound in HIV-1 RNA to ≥ 50 copies/mL, which was subsequently confirmed at following scheduled or unscheduled visit; OR At any visit, a \> 1 log10 increase in HIV-1 RNA from nadir, which was subsequently confirmed at following scheduled or unscheduled visit; * Any participant with HIV-1 RNA ≥ 50 copies/mL at study endpoint or study discontinuation who didn't meet any of criteria above also had protease (PR)/reverse transcriptase (RT), integrase (IN), \&capsid (CA) genotyping \& phenotyping performed.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=1 Participants Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=1 Participants Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part A: Number of Participants Experiencing Any Emergence of Capsid Inhibitor Resistance	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Day 10

Population: Participants in the Post-Monotherapy Resistance Analysis Population were analyzed. One participant in 'Part B: TAF 200 mg' group and one participant in 'Part B: TAF 600 mg' group had assay failure and thus were not included in the analysis.

Outcome measures

Outcome measures
Measure	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 20 mg n=6 Participants Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=4 Participants Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Part B: Number of Participants Experiencing Any Emergence of TAF Resistance	—	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 10 through Day 225

Population: Data was not collected as no participants met the specified Post-Monotherapy Resistance Analysis Population criteria.

TAF Resistance testing was performed for any participant meeting Post-Monotherapy Resistance Analysis Population criteria - it included any participant who received at least 1 dose of study drug/placebo, maintained their study drug regimen, \& met one of the following virologic failure criteria: * HIV-1 RNA ≥50 copies/mL \& \< 1 log10 HIV-1 RNA reduction from D10 at the D57 visit, confirmed at scheduled or unscheduled visit at least 2 weeks following D57 * At any visit following D10, after achieving HIV-1 RNA\< 50 copies/mL, a rebound in HIV-1 RNA to ≥50 copies/mL, which was subsequently confirmed at the following scheduled/unscheduled visit; OR At any visit, a \> 1 log10 increase in HIV-1 RNA from nadir, which was subsequently confirmed at the following scheduled or unscheduled visit; * Any participant with HIV-1 RNA ≥50 copies/mL at study endpoint or study discontinuation who didn't meet any of the criteria above also had PR/RT, IN, and CA genotyping \& phenotyping performed. D = Day

Outcome measures

Outcome data not reported

Adverse Events

Part A: Lenacapavir 20 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part A: Lenacapavir 50 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A: Lenacapavir 150 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part A: Lenacapavir 450 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A: Lenacapavir 750 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A: Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Part B: TAF 200 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part B: TAF 600 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Lenacapavir 20 mg n=6 participants at risk Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 participants at risk Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 participants at risk Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 participants at risk Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=5 participants at risk Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=10 participants at risk Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 200 mg n=7 participants at risk Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg n=5 participants at risk Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Cardiac disorders Acute myocardial infarction	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Cardiac disorders Coronary artery disease	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Part A: Lenacapavir 20 mg n=6 participants at risk Participants received a single dose of lenacapavir 20 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 50 mg n=6 participants at risk Participants received a single dose of lenacapavir 50 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 150 mg n=6 participants at risk Participants received a single dose of lenacapavir 150 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 450 mg n=6 participants at risk Participants received a single dose of lenacapavir 450 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Lenacapavir 750 mg n=5 participants at risk Participants received a single dose of lenacapavir 750 mg subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part A: Placebo n=10 participants at risk Participants received a single dose of placebo matched to lenacapavir subcutaneously in the abdomen on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 200 mg n=7 participants at risk Participants received a single oral dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.	Part B: TAF 600 mg n=5 participants at risk Participants received a single oral dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy started on Day 10 through Day 225.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Urinary tract infection bacterial	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Corneal abrasion	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Seborrhoea	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Exposure to communicable disease	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Cardiac disorders Atrioventricular block first degree	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Ear and labyrinth disorders Excessive cerumen production	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Eye disorders Conjunctivitis allergic	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Eye disorders Eye pain	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Eye disorders Retinal tear	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Eye disorders Vision blurred	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	28.6% 2/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Anogenital dysplasia	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Eructation	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Lip dry	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	28.6% 2/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	60.0% 3/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Proctalgia	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Proctitis	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Rectal discharge	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Umbilical hernia	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Chills	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Influenza like illness	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Injection site bruising	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Injection site erythema	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	66.7% 4/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	33.3% 2/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	40.0% 2/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Injection site induration	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	50.0% 3/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	33.3% 2/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Injection site mass	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Injection site nodule	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	33.3% 2/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	40.0% 2/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Injection site pain	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	66.7% 4/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	66.7% 4/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	66.7% 4/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	80.0% 4/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	30.0% 3/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Injection site swelling	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Oedema peripheral	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Pain	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Peripheral swelling	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Pyrexia	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
General disorders Suprapubic pain	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Immune system disorders Drug hypersensitivity	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Acute sinusitis	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Anal chlamydia infection	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Bronchitis	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Cellulitis	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Gastroenteritis viral	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Hordeolum	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Latent tuberculosis	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	33.3% 2/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	33.3% 2/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Oral candidiasis	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Oropharyngeal gonococcal infection	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Pharyngeal chlamydia infection	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Pharyngitis	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Pharyngitis streptococcal	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Proctitis gonococcal	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Subcutaneous abscess	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Syphilis	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	33.3% 2/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	33.3% 2/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	66.7% 4/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	40.0% 2/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Limb injury	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Investigations Liver function test increased	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Investigations Transaminases increased	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Investigations Weight increased	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Metabolism and nutrition disorders Gout	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Metabolism and nutrition disorders Increased appetite	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	33.3% 2/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	40.0% 2/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoplasmacytoid lymphoma/immunocytoma	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Nervous system disorders Headache	33.3% 2/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 2/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	28.6% 2/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	60.0% 3/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Nervous system disorders Presyncope	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	40.0% 2/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Psychiatric disorders Depression	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Psychiatric disorders Stress	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Renal and urinary disorders Crystalluria	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Renal and urinary disorders Proteinuria	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Renal and urinary disorders Sterile pyuria	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	10.0% 1/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	20.0% 1/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	14.3% 1/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	16.7% 1/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/6 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/10 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/7 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.	0.00% 0/5 • Day 1 through 225 days The Safety Analysis Set included all participants who were randomized/enrolled and received at least 1 dose of study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER