Trial Outcomes & Findings for Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B (NCT NCT01277601)

NCT ID: NCT01277601

Last Updated: 2016-08-26

Results Overview

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 751 participants
• Primary outcome timeframe: Baseline; Week 72
• Results posted on: 2016-08-26

Participant Flow

Participants were enrolled at study sites in North America, Europe, Asia, and Australia. The first participant was screened on 12 April 2011. The last study visit occurred on 17 July 2015.

1597 participants were screened.

Participant milestones

Measure	TDF+Peg-IFN 48 Weeks Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily plus peginterferon α-2a (Peg-IFN) 180 µg subcutaneous (s.c.) injection once weekly for 48 weeks	TDF 48 Weeks + Peg-IFN 16 Weeks TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks	TDF 120 Weeks TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Overall Study STARTED	188	187	190	186
Overall Study COMPLETED	151	139	163	150
Overall Study NOT COMPLETED	37	48	27	36

Reasons for withdrawal

Measure	TDF+Peg-IFN 48 Weeks Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily plus peginterferon α-2a (Peg-IFN) 180 µg subcutaneous (s.c.) injection once weekly for 48 weeks	TDF 48 Weeks + Peg-IFN 16 Weeks TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks	TDF 120 Weeks TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
Overall Study Adverse Event	5	3	0	7
Overall Study Withdrawal by Subject	18	21	8	17
Overall Study Lost to Follow-up	7	9	4	2
Overall Study Physician Decision	3	5	1	6
Overall Study Pregnancy	2	2	4	1
Overall Study Noncompliance with Study Drug	1	3	2	0
Overall Study Subject Never Dosed with Study Drug	1	2	3	1
Overall Study Protocol Violation	0	2	5	0
Overall Study Subject Terminated from Study by Sponsor	0	1	0	2

Baseline Characteristics

Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B

Baseline characteristics by cohort

Measure	TDF+Peg-IFN 48 Weeks n=186 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 48 Weeks + Peg-IFN 16 Week n=184 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks	TDF 120 Weeks n=185 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=185 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Total n=740 Participants Total of all reporting groups
Age, Continuous	38 years STANDARD_DEVIATION 10.7 • n=5 Participants	37 years STANDARD_DEVIATION 9.9 • n=7 Participants	36 years STANDARD_DEVIATION 10.8 • n=5 Participants	38 years STANDARD_DEVIATION 10.5 • n=4 Participants	37 years STANDARD_DEVIATION 10.5 • n=21 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	65 Participants n=7 Participants	64 Participants n=5 Participants	66 Participants n=4 Participants	254 Participants n=21 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	119 Participants n=7 Participants	121 Participants n=5 Participants	119 Participants n=4 Participants	486 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	18 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	182 Participants n=5 Participants	179 Participants n=7 Participants	181 Participants n=5 Participants	177 Participants n=4 Participants	719 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Asian	142 participants n=5 Participants	134 participants n=7 Participants	141 participants n=5 Participants	137 participants n=4 Participants	554 participants n=21 Participants
Race/Ethnicity, Customized Black or African American	5 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	6 participants n=4 Participants	18 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants
Race/Ethnicity, Customized White	36 participants n=5 Participants	45 participants n=7 Participants	39 participants n=5 Participants	41 participants n=4 Participants	161 participants n=21 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	4 participants n=21 Participants
Region of Enrollment Romania	12 participants n=5 Participants	15 participants n=7 Participants	13 participants n=5 Participants	9 participants n=4 Participants	49 participants n=21 Participants
Region of Enrollment Singapore	7 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants	8 participants n=4 Participants	27 participants n=21 Participants
Region of Enrollment Hong Kong	25 participants n=5 Participants	24 participants n=7 Participants	27 participants n=5 Participants	21 participants n=4 Participants	97 participants n=21 Participants
Region of Enrollment United States	19 participants n=5 Participants	17 participants n=7 Participants	23 participants n=5 Participants	26 participants n=4 Participants	85 participants n=21 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants	10 participants n=21 Participants
Region of Enrollment Portugal	0 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants
Region of Enrollment India	10 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants	6 participants n=4 Participants	30 participants n=21 Participants
Region of Enrollment Spain	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	5 participants n=4 Participants	14 participants n=21 Participants
Region of Enrollment Greece	0 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	9 participants n=21 Participants
Region of Enrollment Canada	19 participants n=5 Participants	14 participants n=7 Participants	14 participants n=5 Participants	11 participants n=4 Participants	58 participants n=21 Participants
Region of Enrollment Netherlands	2 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	4 participants n=21 Participants
Region of Enrollment Turkey	5 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	7 participants n=4 Participants	24 participants n=21 Participants
Region of Enrollment Taiwan	20 participants n=5 Participants	15 participants n=7 Participants	12 participants n=5 Participants	19 participants n=4 Participants	66 participants n=21 Participants
Region of Enrollment Korea, Republic of	34 participants n=5 Participants	38 participants n=7 Participants	38 participants n=5 Participants	35 participants n=4 Participants	145 participants n=21 Participants
Region of Enrollment Poland	4 participants n=5 Participants	7 participants n=7 Participants	6 participants n=5 Participants	5 participants n=4 Participants	22 participants n=21 Participants
Region of Enrollment Italy	2 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	11 participants n=21 Participants
Region of Enrollment Australia	10 participants n=5 Participants	14 participants n=7 Participants	15 participants n=5 Participants	14 participants n=4 Participants	53 participants n=21 Participants
Region of Enrollment France	6 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	13 participants n=21 Participants
Region of Enrollment Germany	6 participants n=5 Participants	7 participants n=7 Participants	4 participants n=5 Participants	3 participants n=4 Participants	20 participants n=21 Participants
Hepatitis B Surface Antigen (HBsAg)	3.88 log 10 IU/mL STANDARD_DEVIATION 0.840 • n=5 Participants	3.84 log 10 IU/mL STANDARD_DEVIATION 0.849 • n=7 Participants	3.89 log 10 IU/mL STANDARD_DEVIATION 0.812 • n=5 Participants	3.76 log 10 IU/mL STANDARD_DEVIATION 0.844 • n=4 Participants	3.84 log 10 IU/mL STANDARD_DEVIATION 0.836 • n=21 Participants
Hepatitis B e Antigen (HBeAg) Status Reactive	108 participants n=5 Participants	105 participants n=7 Participants	109 participants n=5 Participants	106 participants n=4 Participants	428 participants n=21 Participants
Hepatitis B e Antigen (HBeAg) Status Nonreactive	78 participants n=5 Participants	79 participants n=7 Participants	76 participants n=5 Participants	79 participants n=4 Participants	312 participants n=21 Participants
Hepatitis B Virus (HBV) DNA	7.06 log 10 IU/mL STANDARD_DEVIATION 1.542 • n=5 Participants	7.13 log 10 IU/mL STANDARD_DEVIATION 1.505 • n=7 Participants	7.02 log 10 IU/mL STANDARD_DEVIATION 1.550 • n=5 Participants	6.94 log 10 IU/mL STANDARD_DEVIATION 1.619 • n=4 Participants	7.04 log 10 IU/mL STANDARD_DEVIATION 1.553 • n=21 Participants
HBV Genotype Genotype A	17 participants n=5 Participants	16 participants n=7 Participants	14 participants n=5 Participants	14 participants n=4 Participants	61 participants n=21 Participants
HBV Genotype Genotype B	50 participants n=5 Participants	51 participants n=7 Participants	49 participants n=5 Participants	53 participants n=4 Participants	203 participants n=21 Participants
HBV Genotype Genotype C	78 participants n=5 Participants	79 participants n=7 Participants	78 participants n=5 Participants	79 participants n=4 Participants	314 participants n=21 Participants
HBV Genotype Genotype D	39 participants n=5 Participants	36 participants n=7 Participants	41 participants n=5 Participants	38 participants n=4 Participants	154 participants n=21 Participants
HBV Genotype Genotype E-H	2 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	8 participants n=21 Participants
Alanine Aminotransferase (ALT)	121.2 U/L STANDARD_DEVIATION 180.82 • n=5 Participants	112.2 U/L STANDARD_DEVIATION 94.44 • n=7 Participants	100.9 U/L STANDARD_DEVIATION 67.65 • n=5 Participants	106.6 U/L STANDARD_DEVIATION 91.51 • n=4 Participants	110.3 U/L STANDARD_DEVIATION 116.94 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline; Week 72

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants in the TDF+Peg-IFN 48 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed by randomized treatment.

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.

The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=186 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=185 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=185 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone	9.05 percentage of participants	0.00 percentage of participants	2.84 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline; Week 72

Population: Full Analysis Set. Participants in the TDF 48 week + Peg-IFN 16 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed.

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.

The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=184 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=185 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=185 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone	2.83 percentage of participants	0.00 percentage of participants	2.84 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline; Weeks 96 and 120

Population: Full Analysis Set

Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.

The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=186 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=184 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=185 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=185 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With HBsAg Loss at Weeks 96 and 120 Week 96	9.69 percentage of participants	3.49 percentage of participants	0.00 percentage of participants	2.84 percentage of participants	—	—	—
Percentage of Participants With HBsAg Loss at Weeks 96 and 120 Week 120	10.36 percentage of participants	3.49 percentage of participants	0.00 percentage of participants	3.51 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline; Weeks 72, 96, and 120

Population: Full Analysis Set

HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate.

The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=186 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=184 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=185 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=185 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 Week 120	10.08 percentage of participants	0.56 percentage of participants	0.00 percentage of participants	2.87 percentage of participants	—	—	—
Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 Week 72	8.05 percentage of participants	0.56 percentage of participants	0.00 percentage of participants	2.87 percentage of participants	—	—	—
Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 Week 96	8.05 percentage of participants	0.56 percentage of participants	0.00 percentage of participants	2.87 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline; Week 72

Population: Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.

Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=76 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=32 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=61 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=44 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=109 Participants TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) n=64 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) n=42 Participants Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 HBeAg Loss	35.5 percentage of participants	15.6 percentage of participants	32.8 percentage of participants	15.9 percentage of participants	14.7 percentage of participants	32.8 percentage of participants	14.3 percentage of participants
Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 HBeAg Seroconversion	28.9 percentage of participants	15.6 percentage of participants	31.1 percentage of participants	13.6 percentage of participants	12.8 percentage of participants	31.3 percentage of participants	14.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 96

Population: Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.

Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=44 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=64 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=44 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=61 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=109 Participants TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) n=37 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) n=69 Participants Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 HBeAg Loss	43.2 percentage of participants	20.3 percentage of participants	45.5 percentage of participants	14.8 percentage of participants	18.3 percentage of participants	37.8 percentage of participants	14.5 percentage of participants
Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 HBeAg Seroconversion	36.4 percentage of participants	18.8 percentage of participants	43.2 percentage of participants	13.1 percentage of participants	16.5 percentage of participants	29.7 percentage of participants	13.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 120

Population: Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.

Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=44 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=64 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=40 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=65 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=109 Participants TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) n=36 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) n=70 Participants Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 HBeAg Loss	38.6 percentage of participants	25.0 percentage of participants	37.5 percentage of participants	23.1 percentage of participants	20.2 percentage of participants	33.3 percentage of participants	18.6 percentage of participants
Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 HBeAg Seroconversion	29.5 percentage of participants	21.9 percentage of participants	35.0 percentage of participants	15.4 percentage of participants	15.6 percentage of participants	25.0 percentage of participants	17.1 percentage of participants

SECONDARY outcome

Timeframe: Week 72

Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=144 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=42 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=131 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=53 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=185 Participants TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) n=128 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) n=57 Participants Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72	15.3 percentage of participants	26.2 percentage of participants	14.5 percentage of participants	15.1 percentage of participants	84.9 percentage of participants	11.7 percentage of participants	40.4 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=83 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=103 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=83 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=101 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=185 Participants TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) n=72 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) n=113 Participants Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96	21.7 percentage of participants	68.0 percentage of participants	15.7 percentage of participants	80.2 percentage of participants	83.8 percentage of participants	13.9 percentage of participants	70.8 percentage of participants

SECONDARY outcome

Timeframe: Week 120

Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=74 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=112 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=69 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=115 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=185 Participants TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) n=68 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) n=117 Participants Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120	32.4 percentage of participants	81.3 percentage of participants	18.8 percentage of participants	83.5 percentage of participants	82.2 percentage of participants	13.2 percentage of participants	82.1 percentage of participants

SECONDARY outcome

Timeframe: Week 72

Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.

Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 72, and in the "Retreated" column for participants who did enter the retreatment phase by Week 72.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=126 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=60 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=118 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=66 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=185 Participants TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) n=120 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) n=65 Participants Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With Normal ALT at Week 72 AASLD Criteria	42.1 percentage of participants	18.3 percentage of participants	40.7 percentage of participants	18.2 percentage of participants	47.6 percentage of participants	35.0 percentage of participants	9.2 percentage of participants
Percentage of Participants With Normal ALT at Week 72 Central Laboratory Criteria	59.5 percentage of participants	40.0 percentage of participants	57.6 percentage of participants	34.8 percentage of participants	72.4 percentage of participants	57.5 percentage of participants	33.8 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.

Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 96, and in the "Retreated" column for participants who did enter the retreatment phase by Week 96.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=81 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=105 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=82 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=102 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=185 Participants TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) n=72 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) n=113 Participants Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With Normal ALT at Week 96 AASLD Criteria	43.2 percentage of participants	42.9 percentage of participants	34.1 percentage of participants	46.1 percentage of participants	48.1 percentage of participants	34.7 percentage of participants	39.8 percentage of participants
Percentage of Participants With Normal ALT at Week 96 Central Laboratory Criteria	55.6 percentage of participants	71.4 percentage of participants	52.4 percentage of participants	73.5 percentage of participants	73.0 percentage of participants	47.2 percentage of participants	68.1 percentage of participants

SECONDARY outcome

Timeframe: Week 120

Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.

Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).

For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the "Not Retreated" column for participants who had not entered the retreatment phase by Week 120, and in the "Retreated" column for participants who did enter the retreatment phase by Week 120.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=74 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=112 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=69 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks n=115 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=185 Participants TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) n=68 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) n=117 Participants Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants With Normal ALT at Week 120 AASLD Criteria	39.2 percentage of participants	54.5 percentage of participants	30.4 percentage of participants	48.7 percentage of participants	48.6 percentage of participants	30.9 percentage of participants	47.0 percentage of participants
Percentage of Participants With Normal ALT at Week 120 Central Laboratory Criteria	44.6 percentage of participants	72.3 percentage of participants	40.6 percentage of participants	78.3 percentage of participants	73.0 percentage of participants	41.2 percentage of participants	73.5 percentage of participants

SECONDARY outcome

Timeframe: Up to 120 weeks

Population: Safety Analysis Set. Participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups were analyzed.

Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.

Outcome measures

Measure	TDF+Peg-IFN 48 Weeks n=186 Participants TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks n=184 Participants TDF 300 mg tablet once daily for 120 weeks	Peg-IFN 48 Weeks n=185 Participants Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF 120 Weeks TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.	Peg-IFN 48 Weeks (Not Retreated) Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase	Peg-IFN 48 Weeks (Retreated) Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
Percentage of Participants Who Required Retreatment	60.2 percentage of participants	62.5 percentage of participants	63.2 percentage of participants	—	—	—	—

Adverse Events

TDF+Peg-IFN 48 Weeks (Not Retreated)

Serious events: 21 serious events

Other events: 147 other events

Deaths: 0 deaths

TDF+Peg-IFN 48 Weeks (Retreated)

Serious events: 7 serious events

Other events: 26 other events

Deaths: 0 deaths

TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated)

Serious events: 18 serious events

Other events: 142 other events

Deaths: 0 deaths

TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

TDF 120 Weeks

Serious events: 13 serious events

Other events: 89 other events

Deaths: 0 deaths

Peg-IFN 48 Weeks (Not Retreated)

Serious events: 18 serious events

Other events: 152 other events

Deaths: 0 deaths

Peg-IFN 48 Weeks (Retreated)

Serious events: 6 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	TDF+Peg-IFN 48 Weeks (Not Retreated) n=186 participants at risk Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days. TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF+Peg-IFN 48 Weeks (Retreated) n=112 participants at risk Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days. TDF 300 mg tablet once daily up to Week 120	TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated) n=184 participants at risk Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days. TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks	TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) n=115 participants at risk Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days. TDF 300 mg tablet once daily up to Week 120	TDF 120 Weeks n=185 participants at risk Adverse events in this reporting group are those occurring during the initial treatment phase (up to 120 weeks plus 30 days). TDF 300 mg tablet once daily for up to 120 weeks	Peg-IFN 48 Weeks (Not Retreated) n=185 participants at risk Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days. Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks (Retreated) n=117 participants at risk Adverse events in this reporting group are those occurring during the retreatment phase (from start of retreatment up to Week 120 plus 30 days). TDF 300 mg tablet once daily up to Week 120
Blood and lymphatic system disorders Thrombocytopenia	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Cardiac disorders Atrial septal defect acquired	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Endocrine disorders Hyperthyroidism	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Abdominal pain	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Haematemesis	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Haemorrhoids	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Hepatobiliary disorders Cholangitis	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Hepatobiliary disorders Cholangitis acute	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.1% 2/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Hepatobiliary disorders Hepatitis	1.6% 3/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.8% 2/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.2% 4/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.8% 7/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Infections and infestations Anal abscess	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Infections and infestations Appendicitis	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Infections and infestations Cellulitis	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Infections and infestations Gastroenteritis	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Infections and infestations Gastroenteritis viral	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Infections and infestations Psoas abscess	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Infections and infestations Sinusitis	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Injury, poisoning and procedural complications Contusion	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Investigations Alanine aminotransferase abnormal	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Investigations Alanine aminotransferase increased	3.2% 6/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 3/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.3% 8/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.8% 7/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Investigations Amylase increased	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Investigations Aspartate aminotransferase increased	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.8% 2/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.1% 2/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Investigations Lipase increased	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Investigations Transaminases increased	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Metabolism and nutrition disorders Cholesterosis	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.89% 1/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of the cervix	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.89% 1/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder neoplasm	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mixed hepatocellular cholangiocarcinoma	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.89% 1/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Nervous system disorders Hepatic encephalopathy	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Nervous system disorders Myelopathy	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Nervous system disorders Neuropathy peripheral	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Psychiatric disorders Anxiety	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Psychiatric disorders Depression	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Reproductive system and breast disorders Prostatitis	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.54% 1/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Skin and subcutaneous tissue disorders Rash	0.00% 0/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.

Other adverse events

Measure	TDF+Peg-IFN 48 Weeks (Not Retreated) n=186 participants at risk Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days. TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	TDF+Peg-IFN 48 Weeks (Retreated) n=112 participants at risk Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days. TDF 300 mg tablet once daily up to Week 120	TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated) n=184 participants at risk Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days. TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks	TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated) n=115 participants at risk Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days. TDF 300 mg tablet once daily up to Week 120	TDF 120 Weeks n=185 participants at risk Adverse events in this reporting group are those occurring during the initial treatment phase (up to 120 weeks plus 30 days). TDF 300 mg tablet once daily for up to 120 weeks	Peg-IFN 48 Weeks (Not Retreated) n=185 participants at risk Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days. Peg-IFN 180 µg s.c. injection once weekly for 48 weeks	Peg-IFN 48 Weeks (Retreated) n=117 participants at risk Adverse events in this reporting group are those occurring during the retreatment phase (from start of retreatment up to Week 120 plus 30 days). TDF 300 mg tablet once daily up to Week 120
Blood and lymphatic system disorders Neutropenia	8.1% 15/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	6.0% 11/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	8.1% 15/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Abdominal pain	3.8% 7/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.89% 1/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.3% 6/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.2% 6/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.4% 10/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Abdominal pain upper	5.9% 11/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.8% 2/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.8% 7/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.8% 7/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.2% 6/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.1% 6/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Diarrhoea	7.0% 13/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.8% 2/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.4% 10/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.9% 11/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	10.3% 19/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.4% 4/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Dyspepsia	4.8% 9/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.89% 1/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.3% 6/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	8.1% 15/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.9% 9/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Gastrointestinal disorders Nausea	14.0% 26/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	13.0% 24/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.6% 3/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.9% 11/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	7.0% 13/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.1% 6/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
General disorders Asthenia	10.8% 20/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.9% 9/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.2% 4/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	6.5% 12/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
General disorders Chills	2.7% 5/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	7.1% 13/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.6% 3/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.9% 11/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
General disorders Fatigue	21.5% 40/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.8% 2/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	17.9% 33/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.5% 4/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	11.4% 21/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	22.2% 41/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.1% 6/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
General disorders Influenza like illness	10.2% 19/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	9.2% 17/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.4% 10/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	9.2% 17/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
General disorders Injection site erythema	6.5% 12/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	6.0% 11/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.4% 10/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
General disorders Malaise	10.8% 20/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	6.5% 12/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.1% 2/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.8% 7/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.6% 3/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
General disorders Pain	4.3% 8/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 5/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.9% 11/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
General disorders Pyrexia	21.0% 39/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.89% 1/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	19.6% 36/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.3% 8/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	23.2% 43/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Infections and infestations Nasopharyngitis	2.7% 5/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 3/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	8.7% 16/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.6% 3/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	10.8% 20/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.2% 6/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.6% 3/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Infections and infestations Upper respiratory tract infection	5.4% 10/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 3/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.9% 9/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	7.8% 9/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	8.6% 16/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.4% 10/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.3% 5/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Metabolism and nutrition disorders Decreased appetite	12.4% 23/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	19.6% 36/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.1% 2/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	9.7% 18/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 9/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 3/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	6.0% 11/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.6% 3/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.2% 4/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.9% 9/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Musculoskeletal and connective tissue disorders Back pain	8.6% 16/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 3/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	6.0% 11/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.6% 3/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.9% 11/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.4% 10/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.6% 3/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.7% 5/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.8% 2/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.1% 2/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.4% 10/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.3% 8/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Musculoskeletal and connective tissue disorders Myalgia	15.6% 29/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	19.6% 36/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.1% 2/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	18.9% 35/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Nervous system disorders Dizziness	10.8% 20/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	9.8% 18/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.9% 9/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	9.2% 17/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.4% 4/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Nervous system disorders Headache	29.0% 54/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 3/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	20.1% 37/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.6% 3/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	8.6% 16/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	28.1% 52/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.4% 4/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Psychiatric disorders Insomnia	10.2% 19/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 3/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	7.6% 14/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	3.2% 6/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	9.7% 18/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Psychiatric disorders Irritability	5.9% 11/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.89% 1/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.1% 2/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.9% 11/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 11/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 3/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.9% 9/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.6% 3/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	6.5% 12/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	8.6% 16/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.6% 3/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.4% 10/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 3/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.7% 5/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.9% 9/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	5.9% 11/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Skin and subcutaneous tissue disorders Alopecia	24.7% 46/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	17.4% 32/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.1% 2/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	24.3% 45/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.85% 1/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Skin and subcutaneous tissue disorders Pruritus	7.5% 14/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	7.6% 14/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	2.2% 4/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	11.4% 21/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.00% 0/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.
Skin and subcutaneous tissue disorders Rash	10.8% 20/186 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.89% 1/112 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	9.2% 17/184 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.87% 1/115 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	0.54% 1/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	4.9% 9/185 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.	1.7% 2/117 • Up to 120 weeks plus 30 days Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants were analyzed by actual treatment received.

Additional Information

Clinical Trial Disclosures

Gilead Sciences

Email: ClinicalTrialDisclosures@gilead.com

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