Trial Outcomes & Findings for A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B (NCT NCT01519960)

NCT ID: NCT01519960

Last Updated: 2022-11-18

Results Overview

HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 165 participants
• Primary outcome timeframe: FU Week 24 (up to 72 weeks overall)
• Results posted on: 2022-11-18

Participant Flow

A total of 211 individuals were screened for entry into the study. Of these, there were 161 participants enrolled in the study and included in the main analyses.

Participant milestones

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Overall Study STARTED	101	50	10
Overall Study Completed Week 48	99	47	10
Overall Study Completed Follow-Up (FU) Week 12	99	26	10
Overall Study Completed FU Week 24	99	15	10
Overall Study Completed FU 5 Year	75	28	5
Overall Study Switch Group	0	33	0
Overall Study COMPLETED	75	28	5
Overall Study NOT COMPLETED	26	22	5

Reasons for withdrawal

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Overall Study Withdrawal from the study	26	22	5

Baseline Characteristics

A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Baseline characteristics by cohort

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis n=10 Participants Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.	Total n=161 Participants Total of all reporting groups
Age, Continuous	10.41 years STANDARD_DEVIATION 4.57 • n=5 Participants	11.2 years STANDARD_DEVIATION 5.01 • n=7 Participants	6.7 years STANDARD_DEVIATION 3.27 • n=5 Participants	10.55 years STANDARD_DEVIATION 4.81 • n=4 Participants
Age, Customized In utero	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized Preterm newborn infants (gestational age < 37 wks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized Children (2-11 years)	53 Participants n=5 Participants	20 Participants n=7 Participants	9 Participants n=5 Participants	82 Participants n=4 Participants
Age, Customized Adolescents (12-17 years)	48 Participants n=5 Participants	30 Participants n=7 Participants	1 Participants n=5 Participants	79 Participants n=4 Participants
Age, Customized Adults (18-64 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized From 65-84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	18 Participants n=7 Participants	2 Participants n=5 Participants	57 Participants n=4 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	32 Participants n=7 Participants	8 Participants n=5 Participants	104 Participants n=4 Participants

PRIMARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B	25.7 percentage of participants 95% Confidence Interval 17.56 • Interval 17.56 to 35.4	6 percentage of participants 95% Confidence Interval 1.25 • Interval 1.25 to 16.55	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B	25.7 percentage of participants 95% Confidence Interval 17.56 • Interval 17.56 to 35.4	6 percentage of participants 95% Confidence Interval 1.25 • Interval 1.25 to 16.55	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B	7.9 percentage of participants 95% Confidence Interval 3.48 • Interval 3.48 to 15.01	0 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 7.11	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B	51.5 percentage of participants 95% Confidence Interval 41.33 • Interval 41.33 to 61.55	12 percentage of participants 95% Confidence Interval 4.53 • Interval 4.53 to 24.31	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B	33.7 percentage of participants 95% Confidence Interval 24.56 • Interval 24.56 to 43.75	4 percentage of participants 95% Confidence Interval 0.49 • Interval 0.49 to 13.71	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B	28.7 percentage of participants 95% Confidence Interval 20.15 • Interval 20.15 to 38.57	2 percentage of participants 95% Confidence Interval 0.05 • Interval 0.05 to 10.65	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B	22.8 percentage of participants 95% Confidence Interval 15.02 • Interval 15.02 to 32.18	4 percentage of participants 95% Confidence Interval 0.49 • Interval 0.49 to 13.71	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B	19.8 percentage of participants 95% Confidence Interval 12.54 • Interval 12.54 to 28.91	2 percentage of participants 95% Confidence Interval 0.05 • Interval 0.05 to 10.65	—

SECONDARY outcome

Timeframe: Week 48

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B	7.9 percentage of participants 95% Confidence Interval 3.48 • Interval 3.48 to 15.01	6 percentage of participants 95% Confidence Interval 1.25 • Interval 1.25 to 16.55	—

SECONDARY outcome

Timeframe: Week 48

The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B	8.9 percentage of participants 95% Confidence Interval 4.16 • Interval 4.16 to 16.24	6 percentage of participants 95% Confidence Interval 1.25 • Interval 1.25 to 16.55	—

SECONDARY outcome

Timeframe: Week 48

HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B	6.9 percentage of participants 95% Confidence Interval 2.83 • Interval 2.83 to 13.76	0 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 7.11	—

SECONDARY outcome

Timeframe: Week 48

The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B	10.9 percentage of participants 95% Confidence Interval 5.56 • Interval 5.56 to 18.65	0 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 7.11	—

SECONDARY outcome

Timeframe: Week 48

Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Normal ALT at EOT/POP in Groups A and B	18.8 percentage of participants 95% Confidence Interval 11.72 • Interval 11.72 to 27.81	22 percentage of participants 95% Confidence Interval 11.53 • Interval 11.53 to 35.96	—

SECONDARY outcome

Timeframe: Week 48

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B	36.6 percentage of participants 95% Confidence Interval 27.27 • Interval 27.27 to 46.81	12 percentage of participants 95% Confidence Interval 4.53 • Interval 4.53 to 24.31	—

SECONDARY outcome

Timeframe: Week 48

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B	30.7 percentage of participants 95% Confidence Interval 21.9 • Interval 21.9 to 40.66	2 percentage of participants 95% Confidence Interval 0.05 • Interval 0.05 to 10.65	—

SECONDARY outcome

Timeframe: Week 48

HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B	18.8 percentage of participants 95% Confidence Interval 11.72 • Interval 11.72 to 27.81	0 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 7.11	—

SECONDARY outcome

Timeframe: Week 48

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B	6.9 percentage of participants 95% Confidence Interval 2.83 • Interval 2.83 to 13.76	6 percentage of participants 95% Confidence Interval 1.25 • Interval 1.25 to 16.55	—

SECONDARY outcome

Timeframe: Week 48

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B	6.9 percentage of participants 95% Confidence Interval 2.83 • Interval 2.83 to 13.76	0 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 7.11	—

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.

Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Quantitative Serum ALT Level in Groups A and B Baseline	2.779 factor of ULN Standard Deviation 2.483	2.878 factor of ULN Standard Deviation 1.997	—
Quantitative Serum ALT Level in Groups A and B Week 1	3.427 factor of ULN Standard Deviation 2.687	—	—
Quantitative Serum ALT Level in Groups A and B Week 2	2.846 factor of ULN Standard Deviation 1.885	—	—
Quantitative Serum ALT Level in Groups A and B Week 4	3.343 factor of ULN Standard Deviation 2.455	—	—
Quantitative Serum ALT Level in Groups A and B Week 8	3.262 factor of ULN Standard Deviation 2.797	—	—
Quantitative Serum ALT Level in Groups A and B Week 12	3.189 factor of ULN Standard Deviation 3.06	—	—
Quantitative Serum ALT Level in Groups A and B Week 18	3.036 factor of ULN Standard Deviation 2.389	—	—
Quantitative Serum ALT Level in Groups A and B Week 24	2.753 factor of ULN Standard Deviation 2.725	2.401 factor of ULN Standard Deviation 2.638	—
Quantitative Serum ALT Level in Groups A and B Week 30	2.587 factor of ULN Standard Deviation 2.128	—	—
Quantitative Serum ALT Level in Groups A and B Week 36	2.45 factor of ULN Standard Deviation 1.856	2.341 factor of ULN Standard Deviation 2.204	—
Quantitative Serum ALT Level in Groups A and B Week 42	2.316 factor of ULN Standard Deviation 1.429	—	—
Quantitative Serum ALT Level in Groups A and B Week 48	2.122 factor of ULN Standard Deviation 1.389	1.954 factor of ULN Standard Deviation 1.371	—
Quantitative Serum ALT Level in Groups A and B FU Week 4	1.303 factor of ULN Standard Deviation 1.74	—	—
Quantitative Serum ALT Level in Groups A and B FU Week 12	2.064 factor of ULN Standard Deviation 2.027	—	—
Quantitative Serum ALT Level in Groups A and B FU Week 24	1.477 factor of ULN Standard Deviation 1.625	1.7 factor of ULN Standard Deviation 1.385	—

SECONDARY outcome

Timeframe: Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.

Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Quantitative HBV DNA Level in Groups A and B Baseline	8.094 log10 IU/mL Standard Deviation 0.986	8.056 log10 IU/mL Standard Deviation 0.987	—
Quantitative HBV DNA Level in Groups A and B Week 12	6.49 log10 IU/mL Standard Deviation 2.009	7.909 log10 IU/mL Standard Deviation 1.267	—
Quantitative HBV DNA Level in Groups A and B Week 24	5.966 log10 IU/mL Standard Deviation 2.398	7.857 log10 IU/mL Standard Deviation 1.327	—
Quantitative HBV DNA Level in Groups A and B Week 36	5.575 log10 IU/mL Standard Deviation 2.513	7.685 log10 IU/mL Standard Deviation 1.608	—
Quantitative HBV DNA Level in Groups A and B Week 48	5.224 log10 IU/mL Standard Deviation 2.701	7.551 log10 IU/mL Standard Deviation 1.761	—
Quantitative HBV DNA Level in Groups A and B FU Week 4	5.739 log10 IU/mL Standard Deviation 2.935	—	—
Quantitative HBV DNA Level in Groups A and B FU Week 12	5.914 log10 IU/mL Standard Deviation 3.065	7.214 log10 IU/mL Standard Deviation 2.46	—
Quantitative HBV DNA Level in Groups A and B FU Week 24	5.707 log10 IU/mL Standard Deviation 3.113	7.2 log10 IU/mL Standard Deviation 2.506	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.

The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Quantitative HBV DNA Level in Groups A and B Week 12	-1.588 log10 IU/mL Standard Deviation 1.625	-0.156 log10 IU/mL Standard Deviation 1.093	—
Change From Baseline in Quantitative HBV DNA Level in Groups A and B Week 24	-2.112 log10 IU/mL Standard Deviation 1.996	-0.168 log10 IU/mL Standard Deviation 1.214	—
Change From Baseline in Quantitative HBV DNA Level in Groups A and B Week 36	-2.525 log10 IU/mL Standard Deviation 2.148	-0.359 log10 IU/mL Standard Deviation 1.411	—
Change From Baseline in Quantitative HBV DNA Level in Groups A and B Week 48	-2.877 log10 IU/mL Standard Deviation 2.374	-0.493 log10 IU/mL Standard Deviation 1.518	—
Change From Baseline in Quantitative HBV DNA Level in Groups A and B FU Week 4	-2.34 log10 IU/mL Standard Deviation 2.582	—	—
Change From Baseline in Quantitative HBV DNA Level in Groups A and B FU Week 12	-2.164 log10 IU/mL Standard Deviation 2.737	-0.86 log10 IU/mL Standard Deviation 2.163	—
Change From Baseline in Quantitative HBV DNA Level in Groups A and B FU Week 24	-2.381 log10 IU/mL Standard Deviation 2.778	-0.587 log10 IU/mL Standard Deviation 2.259	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C	30 percentage of participants 95% Confidence Interval 6.67 • Interval 6.67 to 65.25	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C	0 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 30.85	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C	0 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 30.85	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C	70 percentage of participants 95% Confidence Interval 34.75 • Interval 34.75 to 93.33	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C	70 percentage of participants 95% Confidence Interval 34.75 • Interval 34.75 to 93.33	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C	70 percentage of participants 95% Confidence Interval 34.75 • Interval 34.75 to 93.33	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C	30 percentage of participants 95% Confidence Interval 6.67 • Interval 6.67 to 65.25	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C	30 percentage of participants 95% Confidence Interval 6.67 • Interval 6.67 to 65.25	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C	30 percentage of participants 95% Confidence Interval 6.67 • Interval 6.67 to 65.25	—	—

SECONDARY outcome

Timeframe: Week 48

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBeAg Seroconversion at EOT in Group C	20 percentage of participants 95% Confidence Interval 2.52 • Interval 2.52 to 55.61	—	—

SECONDARY outcome

Timeframe: Week 48

The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Loss of HBeAg at EOT in Group C	20 percentage of participants 95% Confidence Interval 2.52 • Interval 2.52 to 55.61	—	—

SECONDARY outcome

Timeframe: Week 48

HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBsAg Seroconversion at EOT in Group C	0 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 30.85	—	—

SECONDARY outcome

Timeframe: Week 48

The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Loss of HBsAg at EOT in Group C	0 percentage of participants 95% Confidence Interval 0 • Interval 0.0 to 30.85	—	—

SECONDARY outcome

Timeframe: Week 48

Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Normal ALT at EOT in Group C	40 percentage of participants 95% Confidence Interval 12.16 • Interval 12.16 to 73.76	—	—

SECONDARY outcome

Timeframe: Week 48

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C	40 percentage of participants 95% Confidence Interval 12.16 • Interval 12.16 to 73.76	—	—

SECONDARY outcome

Timeframe: Week 48

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C	30 percentage of participants 95% Confidence Interval 6.67 • Interval 6.67 to 65.25	—	—

SECONDARY outcome

Timeframe: Week 48

HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA Undetectable at EOT in Group C	20 percentage of participants 95% Confidence Interval 2.52 • Interval 2.52 to 55.61	—	—

SECONDARY outcome

Timeframe: Week 48

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C	20 percentage of participants 95% Confidence Interval 2.52 • Interval 2.52 to 55.61	—	—

SECONDARY outcome

Timeframe: Week 48

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C	20 percentage of participants 95% Confidence Interval 2.52 • Interval 2.52 to 55.61	—	—

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Quantitative Serum ALT Level in Group C FU Week 4	1.136 factor of ULN Standard Deviation 0.506	—	—
Quantitative Serum ALT Level in Group C FU Week 12	1.521 factor of ULN Standard Deviation 0.755	—	—
Quantitative Serum ALT Level in Group C FU Week 24	1.549 factor of ULN Standard Deviation 1.595	—	—
Quantitative Serum ALT Level in Group C Baseline	2.804 factor of ULN Standard Deviation 1.118	—	—
Quantitative Serum ALT Level in Group C Week 1	3.117 factor of ULN Standard Deviation 1.322	—	—
Quantitative Serum ALT Level in Group C Week 2	2.896 factor of ULN Standard Deviation 1.304	—	—
Quantitative Serum ALT Level in Group C Week 4	2.444 factor of ULN Standard Deviation 1.727	—	—
Quantitative Serum ALT Level in Group C Week 8	2.703 factor of ULN Standard Deviation 2.035	—	—
Quantitative Serum ALT Level in Group C Week 12	2.793 factor of ULN Standard Deviation 1.288	—	—
Quantitative Serum ALT Level in Group C Week 18	2.215 factor of ULN Standard Deviation 1.032	—	—
Quantitative Serum ALT Level in Group C Week 24	1.887 factor of ULN Standard Deviation 1.095	—	—
Quantitative Serum ALT Level in Group C Week 30	2.22 factor of ULN Standard Deviation 1.553	—	—
Quantitative Serum ALT Level in Group C Week 36	2.172 factor of ULN Standard Deviation 1.09	—	—
Quantitative Serum ALT Level in Group C Week 42	1.593 factor of ULN Standard Deviation 0.516	—	—
Quantitative Serum ALT Level in Group C Week 48	1.645 factor of ULN Standard Deviation 1.242	—	—

SECONDARY outcome

Timeframe: Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Quantitative HBV DNA Level in Group C Baseline	7.866 log10 IU/mL Standard Deviation 0.977	—	—
Quantitative HBV DNA Level in Group C Week 12	5.782 log10 IU/mL Standard Deviation 1.771	—	—
Quantitative HBV DNA Level in Group C Week 24	5.599 log10 IU/mL Standard Deviation 2.386	—	—
Quantitative HBV DNA Level in Group C Week 36	5.2 log10 IU/mL Standard Deviation 2.451	—	—
Quantitative HBV DNA Level in Group C Week 48	5.319 log10 IU/mL Standard Deviation 2.747	—	—
Quantitative HBV DNA Level in Group C FU Week 4	4.604 log10 IU/mL Standard Deviation 2.442	—	—
Quantitative HBV DNA Level in Group C FU Week 12	4.252 log10 IU/mL Standard Deviation 2.596	—	—
Quantitative HBV DNA Level in Group C FU Week 24	3.694 log10 IU/mL Standard Deviation 3.127	—	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Quantitative HBV DNA Level in Group C Week 48	-2.546 log10 IU/mL Standard Deviation 2.14	—	—
Change From Baseline in Quantitative HBV DNA Level in Group C FU Week 4	-3.262 log10 IU/mL Standard Deviation 2.102	—	—
Change From Baseline in Quantitative HBV DNA Level in Group C Week 12	-2.084 log10 IU/mL Standard Deviation 1.1	—	—
Change From Baseline in Quantitative HBV DNA Level in Group C Week 24	-2.267 log10 IU/mL Standard Deviation 1.595	—	—
Change From Baseline in Quantitative HBV DNA Level in Group C Week 36	-2.529 log10 IU/mL Standard Deviation 1.879	—	—
Change From Baseline in Quantitative HBV DNA Level in Group C FU Week 12	-3.613 log10 IU/mL Standard Deviation 2.519	—	—
Change From Baseline in Quantitative HBV DNA Level in Group C FU Week 24	-4.15 log10 IU/mL Standard Deviation 2.904	—	—

SECONDARY outcome

Timeframe: Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)

AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h*ng/mL). PK Substudy Population: All participants who consented to participate in the PK substudy. "Number of subjects analyzed" reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=161 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category 0.54-0.74 m^2	3320 h*ng/mL Interval 633.0 to 5064.0	—	—
Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category 0.75-1.08 m^2	4037 h*ng/mL Interval 1897.0 to 6916.0	—	—
Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category 1.09-1.51 m^2	2765 h*ng/mL Interval 1750.0 to 4392.0	—	—
Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category >1.51 m^2	3448 h*ng/mL Interval 1914.0 to 5000.0	—	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=48 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B Week 12	1 percentage of participants	0 percentage of participants	—
Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B Week 24	5 percentage of participants	8.5 percentage of participants	—
Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B Week 36	4 percentage of participants	4.2 percentage of participants	—
Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B Week 48	6.1 percentage of participants	2.1 percentage of participants	—
Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B FU Week 12	10.9 percentage of participants	4.2 percentage of participants	—
Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B FU Week 24	12 percentage of participants	6.7 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.

The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=48 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B Week 4	2 percentage of participants	—	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B Week 8	5 percentage of participants	—	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B Week 12	5.1 percentage of participants	2.1 percentage of participants	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B Week 18	8.1 percentage of participants	—	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B Week 24	16 percentage of participants	8.5 percentage of participants	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B Week 30	13.1 percentage of participants	—	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B Week 36	11.3 percentage of participants	8.3 percentage of participants	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B Week 42	13.1 percentage of participants	—	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B Week 48	12.5 percentage of participants	8.5 percentage of participants	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B FU Week 4	8.1 percentage of participants	—	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B FU Week 12	6.9 percentage of participants	20.8 percentage of participants	—
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B FU Week 24	11 percentage of participants	20 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Quantitative HBeAg Level in Groups A and B Baseline	2.736 log10 PEIU/mL Standard Deviation 0.502	2.568 log10 PEIU/mL Standard Deviation 0.65	—
Quantitative HBeAg Level in Groups A and B Week 12	2.09 log10 PEIU/mL Standard Deviation 0.879	2.391 log10 PEIU/mL Standard Deviation 0.878	—
Quantitative HBeAg Level in Groups A and B Week 24	1.865 log10 PEIU/mL Standard Deviation 0.956	2.36 log10 PEIU/mL Standard Deviation 0.896	—
Quantitative HBeAg Level in Groups A and B Week 36	1.604 log10 PEIU/mL Standard Deviation 0.991	2.272 log10 PEIU/mL Standard Deviation 0.985	—
Quantitative HBeAg Level in Groups A and B Week 48	1.466 log10 PEIU/mL Standard Deviation 1.053	2.124 log10 PEIU/mL Standard Deviation 1.091	—
Quantitative HBeAg Level in Groups A and B FU Week 24	1.537 log10 PEIU/mL Standard Deviation 1.334	2.217 log10 PEIU/mL Standard Deviation 1.395	—

SECONDARY outcome

Timeframe: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Quantitative HBsAg Level in Groups A and B Baseline	4.309 log10 IU/mL Standard Deviation 0.687	4.383 log10 IU/mL Standard Deviation 0.721	—
Quantitative HBsAg Level in Groups A and B Week 12	3.844 log10 IU/mL Standard Deviation 1.186	4.299 log10 IU/mL Standard Deviation 0.809	—
Quantitative HBsAg Level in Groups A and B Week 24	3.509 log10 IU/mL Standard Deviation 1.507	4.336 log10 IU/mL Standard Deviation 0.732	—
Quantitative HBsAg Level in Groups A and B Week 36	3.265 log10 IU/mL Standard Deviation 1.661	4.272 log10 IU/mL Standard Deviation 0.726	—
Quantitative HBsAg Level in Groups A and B Week 48	3.078 log10 IU/mL Standard Deviation 1.769	4.215 log10 IU/mL Standard Deviation 0.718	—
Quantitative HBsAg Level in Groups A and B FU Week 24	3.37 log10 IU/mL Standard Deviation 1.63	4.394 log10 IU/mL Standard Deviation 0.939	—

SECONDARY outcome

Timeframe: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Quantitative HBeAg Level in Group C Baseline	2.344 log10 PEIU/mL Standard Deviation 0.981	—	—
Quantitative HBeAg Level in Group C Week 12	1.62 log10 PEIU/mL Standard Deviation 1.288	—	—
Quantitative HBeAg Level in Group C Week 24	1.802 log10 PEIU/mL Standard Deviation 1.14	—	—
Quantitative HBeAg Level in Group C Week 36	1.561 log10 PEIU/mL Standard Deviation 1.178	—	—
Quantitative HBeAg Level in Group C Week 48	1.429 log10 PEIU/mL Standard Deviation 1.259	—	—
Quantitative HBeAg Level in Group C FU Week 24	1.442 log10 PEIU/mL Standard Deviation 1.416	—	—

SECONDARY outcome

Timeframe: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Quantitative HBsAg Level in Group C Week 24	3.515 log10 IU/mL Standard Deviation 1.113 • Interval 1.113 to	—	—
Quantitative HBsAg Level in Group C Baseline	4.225 log10 IU/mL Standard Deviation 0.518 • Interval 0.518 to	—	—
Quantitative HBsAg Level in Group C Week 12	3.829 log10 IU/mL Standard Deviation 0.589 • Interval 0.589 to	—	—
Quantitative HBsAg Level in Group C Week 36	3.282 log10 IU/mL Standard Deviation 1.263 • Interval 1.263 to	—	—
Quantitative HBsAg Level in Group C Week 48	3.215 log10 IU/mL Standard Deviation 1.352 • Interval 1.352 to	—	—
Quantitative HBsAg Level in Group C FU Week 24	3.137 log10 IU/mL Standard Deviation 1.463 • Interval 1.463 to	—	—

SECONDARY outcome

Timeframe: Week 48; FU Week 24 (up to 72 weeks overall)

Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis. Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=44 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=25 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis n=6 Participants Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C Week 48	-0.49 kPa Standard Deviation 2.151	0.376 kPa Standard Deviation 2.719	-1.517 kPa Standard Deviation 1.685
Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C FU Week 24	-1.026 kPa Standard Deviation 2.269	-0.72 kPa Standard Deviation 2.633	-1.7 kPa Standard Deviation 1.033

SECONDARY outcome

Timeframe: Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)

The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With >15% Drop in Height Percentile for Age in Group C Week 30	20 percentage of participants	—	—
Percentage of Participants With >15% Drop in Height Percentile for Age in Group C Week 36	10 percentage of participants	—	—
Percentage of Participants With >15% Drop in Height Percentile for Age in Group C FU Week 4	10 percentage of participants	—	—
Percentage of Participants With >15% Drop in Height Percentile for Age in Group C FU Week 12	10 percentage of participants	—	—
Percentage of Participants With >15% Drop in Height Percentile for Age in Group C FU Week 24	20 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=49 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Height for Age Z-Score in Groups A and B Baseline	0.271 standard deviations Standard Deviation 1.149	-0.062 standard deviations Standard Deviation 1.17	—
Change From Baseline in Height for Age Z-Score in Groups A and B Week 12	0.011 standard deviations Standard Deviation 0.258	-0.006 standard deviations Standard Deviation 0.185	—
Change From Baseline in Height for Age Z-Score in Groups A and B Week 24	-0.04 standard deviations Standard Deviation 0.293	-0.071 standard deviations Standard Deviation 0.264	—
Change From Baseline in Height for Age Z-Score in Groups A and B Week 36	-0.056 standard deviations Standard Deviation 0.337	-0.025 standard deviations Standard Deviation 0.328	—
Change From Baseline in Height for Age Z-Score in Groups A and B Week 48	-0.099 standard deviations Standard Deviation 0.365	-0.013 standard deviations Standard Deviation 0.284	—
Change From Baseline in Height for Age Z-Score in Groups A and B FU Week 12	-0.112 standard deviations Standard Deviation 0.404	-0.037 standard deviations Standard Deviation 0.243	—
Change From Baseline in Height for Age Z-Score in Groups A and B FU Week 24	-0.117 standard deviations Standard Deviation 0.429	-0.079 standard deviations Standard Deviation 0.282	—

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.

The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=49 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Weight for Age Z-Score in Groups A and B FU Week 12	-0.089 standard deviations Standard Deviation 0.384	-0.263 standard deviations Standard Deviation 0.333	—
Change From Baseline in Weight for Age Z-Score in Groups A and B FU Week 24	-0.046 standard deviations Standard Deviation 0.452	-0.322 standard deviations Standard Deviation 0.325	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Baseline	0.106 standard deviations Standard Deviation 1.154	-0.047 standard deviations Standard Deviation 1.154	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 1	-0.024 standard deviations Standard Deviation 0.089	—	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 2	-0.023 standard deviations Standard Deviation 0.108	—	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 4	-0.048 standard deviations Standard Deviation 0.158	—	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 8	-0.082 standard deviations Standard Deviation 0.228	—	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 12	-0.09 standard deviations Standard Deviation 0.267	-0.04 standard deviations Standard Deviation 0.241	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 18	-0.155 standard deviations Standard Deviation 0.309	—	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 24	-0.165 standard deviations Standard Deviation 0.35	-0.09 standard deviations Standard Deviation 0.323	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 30	-0.189 standard deviations Standard Deviation 0.372	—	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 36	-0.192 standard deviations Standard Deviation 0.395	-0.057 standard deviations Standard Deviation 0.338	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 42	-0.24 standard deviations Standard Deviation 0.375	—	—
Change From Baseline in Weight for Age Z-Score in Groups A and B Week 48	-0.214 standard deviations Standard Deviation 0.371	-0.082 standard deviations Standard Deviation 0.343	—
Change From Baseline in Weight for Age Z-Score in Groups A and B FU Week 4	-0.156 standard deviations Standard Deviation 0.346	—	—

SECONDARY outcome

Timeframe: Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)

The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Height for Age Z-Score in Group C Baseline	0.586 standard deviations Standard Deviation 0.947 • Interval 0.947 to	—	—
Change From Baseline in Height for Age Z-Score in Group C Week 12	0.07 standard deviations Standard Deviation 0.492 • Interval 0.492 to	—	—
Change From Baseline in Height for Age Z-Score in Group C Week 24	0.262 standard deviations Standard Deviation 0.42 • Interval 0.42 to	—	—
Change From Baseline in Height for Age Z-Score in Group C Week 36	0.3 standard deviations Standard Deviation 0.601 • Interval 0.601 to	—	—
Change From Baseline in Height for Age Z-Score in Group C Week 48	0.19 standard deviations Standard Deviation 0.683 • Interval 0.683 to	—	—
Change From Baseline in Height for Age Z-Score in Group C FU Week 12	0.205 standard deviations Standard Deviation 0.611 • Interval 0.611 to	—	—
Change From Baseline in Height for Age Z-Score in Group C FU Week 24	0.064 standard deviations Standard Deviation 0.634 • Interval 0.634 to	—	—

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Weight for Age Z-Score in Group C Baseline	0.187 standard deviations Standard Deviation 1.141	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 1	-0.044 standard deviations Standard Deviation 0.052	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 2	-0.023 standard deviations Standard Deviation 0.107	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 4	0.049 standard deviations Standard Deviation 0.243	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 8	-0.041 standard deviations Standard Deviation 0.198	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 12	0.012 standard deviations Standard Deviation 0.288	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 18	-0.018 standard deviations Standard Deviation 0.377	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 24	-0.089 standard deviations Standard Deviation 0.245	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 30	-0.094 standard deviations Standard Deviation 0.34	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 36	0 standard deviations Standard Deviation 0.443	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 42	-0.032 standard deviations Standard Deviation 0.344	—	—
Change From Baseline in Weight for Age Z-Score in Group C Week 48	-0.208 standard deviations Standard Deviation 0.374	—	—
Change From Baseline in Weight for Age Z-Score in Group C FU Week 4	-0.054 standard deviations Standard Deviation 0.35	—	—
Change From Baseline in Weight for Age Z-Score in Group C FU Week 12	-0.156 standard deviations Standard Deviation 0.29	—	—
Change From Baseline in Weight for Age Z-Score in Group C FU Week 24	-0.161 standard deviations Standard Deviation 0.309	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C	30 percentage of participants 95% Confidence Interval 6.67 • Interval 6.67 to 65.25	—	—

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.

The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 30	-0.1 factor of ULN Standard Deviation 3.163	—	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 36	-0.302 factor of ULN Standard Deviation 2.8	-0.51 factor of ULN Standard Deviation 1.835	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 42	-0.436 factor of ULN Standard Deviation 2.732	—	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 48	-0.63 factor of ULN Standard Deviation 2.652	-0.939 factor of ULN Standard Deviation 1.914	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B FU Week 4	-1.474 factor of ULN Standard Deviation 2.889	—	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 1	0.606 factor of ULN Standard Deviation 1.565	—	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 2	0.06 factor of ULN Standard Deviation 2.283	—	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 4	0.564 factor of ULN Standard Deviation 3.026	—	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 8	0.463 factor of ULN Standard Deviation 3.225	—	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 12	0.415 factor of ULN Standard Deviation 3.732	0.598 factor of ULN Standard Deviation 5.934	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 18	0.288 factor of ULN Standard Deviation 3.332	—	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B Week 24	0.004 factor of ULN Standard Deviation 3.496	-0.462 factor of ULN Standard Deviation 2.311	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B FU Week 12	-0.736 factor of ULN Standard Deviation 2.972	—	—
Change From Baseline in Quantitative Serum ALT Level in Groups A and B FU Week 24	-1.302 factor of ULN Standard Deviation 2.766	-0.701 factor of ULN Standard Deviation 2.22	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. ITT Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=92 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=43 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Quantitative HBeAg Level in Groups A and B Week 12	-0.583 log10 PEIU/mL Standard Deviation 0.672	-0.225 log10 PEIU/mL Standard Deviation 0.497	—
Change From Baseline in Quantitative HBeAg Level in Groups A and B Week 24	-0.834 log10 PEIU/mL Standard Deviation 0.805	-0.261 log10 PEIU/mL Standard Deviation 0.612	—
Change From Baseline in Quantitative HBeAg Level in Groups A and B Week 36	1.123 log10 PEIU/mL Standard Deviation 0.91	-0.3 log10 PEIU/mL Standard Deviation 0.621	—
Change From Baseline in Quantitative HBeAg Level in Groups A and B Week 48	-1.28 log10 PEIU/mL Standard Deviation 1.043	-0.491 log10 PEIU/mL Standard Deviation 0.74	—
Change From Baseline in Quantitative HBeAg Level in Groups A and B FU Week 24	-1.24 log10 PEIU/mL Standard Deviation 1.205	-0.452 log10 PEIU/mL Standard Deviation 0.793	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=44 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Quantitative HBsAg Level in Groups A and B Week 12	-0.444 log10 IU/mL Standard Deviation 1.021	-0.081 log10 IU/mL Standard Deviation 0.356	—
Change From Baseline in Quantitative HBsAg Level in Groups A and B Week 24	-0.798 log10 IU/mL Standard Deviation 1.343	-0.032 log10 IU/mL Standard Deviation 0.392	—
Change From Baseline in Quantitative HBsAg Level in Groups A and B Week 36	-1.051 log10 IU/mL Standard Deviation 1.534	-0.126 log10 IU/mL Standard Deviation 0.26	—
Change From Baseline in Quantitative HBsAg Level in Groups A and B FU Week 24	-0.936 log10 IU/mL Standard Deviation 1.491	-0.204 log10 IU/mL Standard Deviation 0.316	—
Change From Baseline in Quantitative HBsAg Level in Groups A and B Week 48	-1.239 log10 IU/mL Standard Deviation 1.652	-0.188 log10 IU/mL Standard Deviation 0.285	—

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)

The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Quantitative Serum ALT Level in Group C Week 1	0.313 factor of ULN Standard Deviation 0.414	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C Week 2	0.091 factor of ULN Standard Deviation 0.991	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C Week 42	-1.211 factor of ULN Standard Deviation 1.05	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C Week 48	-1.104 factor of ULN Standard Deviation 1.084	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C FU Week 4	-1.669 factor of ULN Standard Deviation 0.95	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C FU Week 12	-1.283 factor of ULN Standard Deviation 1.501	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C Week 4	-0.361 factor of ULN Standard Deviation 1.566	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C Week 8	-0.101 factor of ULN Standard Deviation 1.895	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C Week 12	-0.012 factor of ULN Standard Deviation 1.613	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C Week 18	-0.589 factor of ULN Standard Deviation 0.996	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C Week 24	-0.917 factor of ULN Standard Deviation 1.31	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C Week 30	-0.584 factor of ULN Standard Deviation 1.73	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C Week 36	-0.633 factor of ULN Standard Deviation 1.455	—	—
Change From Baseline in Quantitative Serum ALT Level in Group C FU Week 24	-1.256 factor of ULN Standard Deviation 1.757	—	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. "Number of subjects analyzed" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Quantitative HBeAg Level in Group C Week 12	-0.779 log10 PEIU/mL Standard Deviation 0.645	—	—
Change From Baseline in Quantitative HBeAg Level in Group C Week 24	-0.817 log10 PEIU/mL Standard Deviation 0.678	—	—
Change From Baseline in Quantitative HBeAg Level in Group C Week 36	-0.817 log10 PEIU/mL Standard Deviation 0.685	—	—
Change From Baseline in Quantitative HBeAg Level in Group C Week 48	-0.762 log10 PEIU/mL Standard Deviation 0.818	—	—
Change From Baseline in Quantitative HBeAg Level in Group C FU Week 24	-0.742 log10 PEIU/mL Standard Deviation 0.84	—	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)

The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=10 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Change From Baseline in Quantitative HBsAg Level in Group C Week 12	-0.397 log10 IU/mL Standard Deviation 0.428 • Interval 0.428 to	—	—
Change From Baseline in Quantitative HBsAg Level in Group C Week 24	-0.71 log10 IU/mL Standard Deviation 0.712 • Interval 0.712 to	—	—
Change From Baseline in Quantitative HBsAg Level in Group C Week 36	-0.943 log10 IU/mL Standard Deviation 0.913 • Interval 0.913 to	—	—
Change From Baseline in Quantitative HBsAg Level in Group C Week 48	-1.01 log10 IU/mL Standard Deviation 1.019 • Interval 1.019 to	—	—
Change From Baseline in Quantitative HBsAg Level in Group C FU Week 24	-1.088 log10 IU/mL Standard Deviation 1.141 • Interval 1.141 to	—	—

SECONDARY outcome

Timeframe: Baseline, FU Years: 1, 2, 3, 4, 5

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=50 Participants Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B Fu Year 3	46.5 percentage of subjects 95% Confidence Interval 36.55 • Interval 36.55 to 56.73	6.08 percentage of subjects 95% Confidence Interval 1.25 • Interval 1.25 to 16.55	—
Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B Baseline	0.00 percentage of subjects 95% Confidence Interval 0.00 • Interval 0.0 to 3.59	0.00 percentage of subjects 95% Confidence Interval 0.00 • Interval 0.0 to 7.11	—
Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B Fu Year 1	32.7 percentage of subjects 95% Confidence Interval 23.67 • Interval 23.67 to 42.72	6.08 percentage of subjects 95% Confidence Interval 1.25 • Interval 1.25 to 16.55	—
Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B Fu Year 2	33.7 percentage of subjects 95% Confidence Interval 24.56 • Interval 24.56 to 43.75	6.08 percentage of subjects 95% Confidence Interval 1.25 • Interval 1.25 to 16.55	—
Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B Fu Year 4	30.7 percentage of subjects 95% Confidence Interval 21.90 • Interval 21.9 to 40.66	8.00 percentage of subjects 95% Confidence Interval 2.22 • Interval 2.22 to 19.23	—
Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B Fu Year 5	5.9 percentage of subjects 95% Confidence Interval 2.21 • Interval 2.21 to 12.48	0.00 percentage of subjects 95% Confidence Interval 0.00 • Interval 0.0 to 7.11	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=33 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group	30.3 percentage of participants Interval 15.59 to 48.71	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=33 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group	9.1 percentage of participants Interval 1.92 to 24.33	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=33 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group	12.1 percentage of participants Interval 3.4 to 28.2	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=33 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group	42.4 percentage of participants Interval 25.48 to 60.78	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=33 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group	36.4 percentage of participants Interval 20.4 to 54.88	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=33 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group	27.3 percentage of participants Interval 13.3 to 45.52	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=33 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group	18.2 percentage of participants Interval 6.98 to 35.46	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=33 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group	27.3 percentage of participants Interval 13.3 to 45.52	—	—

SECONDARY outcome

Timeframe: FU Week 24 (up to 72 weeks overall)

HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.

Outcome measures

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=33 Participants Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group	21.2 percentage of participants Interval 8.98 to 38.91	—	—

Adverse Events

Group A: PEG-IFN Monotherapy Without Advanced Fibrosis

Serious events: 6 serious events

Other events: 80 other events

Deaths: 0 deaths

Group B: Untreated Control Without Advanced Fibrosis

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Group C: PEG-IFN Monotherapy With Advanced Fibrosis

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group D: Switch to PEG-IFN Monotherapy

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Group A - Long Term Follow-up

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Group B - Long Term Follow-up

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Group C Long Term Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group D - Long Term Follow-up

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 participants at risk Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=49 participants at risk Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis n=10 participants at risk Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.	Group D: Switch to PEG-IFN Monotherapy n=33 participants at risk Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up	Group A - Long Term Follow-up n=101 participants at risk Participants without advanced fibrosis: 4.5-year extended follow-up	Group B - Long Term Follow-up n=49 participants at risk Participants without advanced fibrosis: 4.5-year extended follow-up	Group C Long Term Follow-up n=10 participants at risk Participants with advanced fibrosis: 4.5-year extended follow-up	Group D - Long Term Follow-up n=33 participants at risk Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up
Investigations Alanine aminotransferase increased	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Investigations Aspartate aminotransferase increased	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Psychiatric disorders Suicidal ideation	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Renal and urinary disorders Nephropathy	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Musculoskeletal and connective tissue disorders Osteochondrosis	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Hepatitis B	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Latent tuberculosis	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Microsporum infection	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Pneumonia	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Tonsillitis	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population

Other adverse events

Measure	Group A: PEG-IFN Monotherapy Without Advanced Fibrosis n=101 participants at risk Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.	Group B: Untreated Control Without Advanced Fibrosis n=49 participants at risk Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up.	Group C: PEG-IFN Monotherapy With Advanced Fibrosis n=10 participants at risk Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg.	Group D: Switch to PEG-IFN Monotherapy n=33 participants at risk Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up	Group A - Long Term Follow-up n=101 participants at risk Participants without advanced fibrosis: 4.5-year extended follow-up	Group B - Long Term Follow-up n=49 participants at risk Participants without advanced fibrosis: 4.5-year extended follow-up	Group C Long Term Follow-up n=10 participants at risk Participants with advanced fibrosis: 4.5-year extended follow-up	Group D - Long Term Follow-up n=33 participants at risk Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up
Blood and lymphatic system disorders Neutropenia	2.0% 2/101 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Vascular disorders Hypertension	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
General disorders Asthenia	9.9% 10/101 • Number of events 26 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	12.1% 4/33 • Number of events 8 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	30.3% 10/33 • Number of events 10 • From Baseline to approximately 4.5 years Safety Population
General disorders Fatigue	8.9% 9/101 • Number of events 12 • From Baseline to approximately 4.5 years Safety Population	4.1% 2/49 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	9.1% 3/33 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	12.1% 4/33 • Number of events 4 • From Baseline to approximately 4.5 years Safety Population
General disorders Influenza like illness	14.9% 15/101 • Number of events 18 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	9.1% 3/33 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population
General disorders Injection site pain	3.0% 3/101 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
General disorders Pyrexia	48.5% 49/101 • Number of events 107 • From Baseline to approximately 4.5 years Safety Population	10.2% 5/49 • Number of events 8 • From Baseline to approximately 4.5 years Safety Population	80.0% 8/10 • Number of events 14 • From Baseline to approximately 4.5 years Safety Population	51.5% 17/33 • Number of events 35 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Psychiatric disorders Irritability	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	9.1% 3/33 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population
Injury, poisoning and procedural complications Contusion	5.0% 5/101 • Number of events 8 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Investigations Alanine aminotransferase increased	8.9% 9/101 • Number of events 10 • From Baseline to approximately 4.5 years Safety Population	8.2% 4/49 • Number of events 4 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	3.0% 3/101 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	21.2% 7/33 • Number of events 7 • From Baseline to approximately 4.5 years Safety Population
Investigations Aspartate aminotransferase increased	8.9% 9/101 • Number of events 10 • From Baseline to approximately 4.5 years Safety Population	6.1% 3/49 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	2.0% 2/101 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	9.1% 3/33 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population
Investigations Body temperature increased	2.0% 2/101 • Number of events 4 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	9.1% 3/33 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Respiratory, thoracic and mediastinal disorders Cough	13.9% 14/101 • Number of events 17 • From Baseline to approximately 4.5 years Safety Population	6.1% 3/49 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population	30.0% 3/10 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	2.0% 2/101 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.0% 3/101 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population	6.1% 3/49 • Number of events 4 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.9% 6/101 • Number of events 6 • From Baseline to approximately 4.5 years Safety Population	8.2% 4/49 • Number of events 6 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Nervous system disorders Dizziness	5.9% 6/101 • Number of events 20 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Nervous system disorders Headache	29.7% 30/101 • Number of events 71 • From Baseline to approximately 4.5 years Safety Population	4.1% 2/49 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	40.0% 4/10 • Number of events 9 • From Baseline to approximately 4.5 years Safety Population	33.3% 11/33 • Number of events 14 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	51.5% 17/33 • Number of events 17 • From Baseline to approximately 4.5 years Safety Population
Gastrointestinal disorders Abdominal pain	18.8% 19/101 • Number of events 30 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	12.1% 4/33 • Number of events 6 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population
Gastrointestinal disorders Nausea	6.9% 7/101 • Number of events 10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	30.0% 3/10 • Number of events 6 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population
Gastrointestinal disorders Vomiting	13.9% 14/101 • Number of events 16 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	30.0% 3/10 • Number of events 4 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population
Skin and subcutaneous tissue disorders Alopecia	5.9% 6/101 • Number of events 9 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population
Skin and subcutaneous tissue disorders Pruritus	3.0% 3/101 • Number of events 4 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Skin and subcutaneous tissue disorders Rash	9.9% 10/101 • Number of events 14 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 3/101 • Number of events 5 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 2/101 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	9.1% 3/33 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population
Metabolism and nutrition disorders Decreased appetite	6.9% 7/101 • Number of events 7 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Nasopharyngitis	6.9% 7/101 • Number of events 17 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	9.1% 3/33 • Number of events 4 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	15.2% 5/33 • Number of events 5 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Oral herpes	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	9.1% 3/33 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Upper respiratory tract infection	8.9% 9/101 • Number of events 14 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Viral infection	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Respiratory, thoracic and mediastinal disorders Epistaxis	7.9% 8/101 • Number of events 8 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	20.0% 2/10 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Peritonsillar abscess	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	10.0% 1/10 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Chronic sinusitis	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Gingiviti	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Helminthic infection	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Respiratory tract infection	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Respiratory tract infection viral	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Rhinitis	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Tuberculous pleurisy	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Skin and subcutaneous tissue disorders Eczema	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Skin and subcutaneous tissue disorders Skin depigmentation	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Skin and subcutaneous tissue disorders Urticardia	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	4.1% 2/49 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
General disorders Peripheral swelling	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Investigations Alpha hydroxybutyrate dehydrogenase increased	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Investigations Blood creatine phosphokinase increased	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Investigations Blood creatine phosphokinase mb increased	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Investigations Blood lactate dehydrogenase increased	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Investigations Hepatitis B DNA increased	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Gastrointestinal disorders Abdominal discomfort	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Gastrointestinal disorders Food poisoning	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Congenital, familial and genetic disorders Duane's syndrome	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Immune system disorders Seasonal allergy	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Injury, poisoning and procedural complications Joint injury	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Vascular disorders Haematoma	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Eye disorders Hypermetropia	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	2.0% 2/101 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Eye disorders Accommodation disorder	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Eye disorders Amblyopia	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Eye disorders Astigmatism	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Tonsillitis	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.99% 1/101 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Renal and urinary disorders Renal cyst	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	2.0% 1/49 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Cardiac disorders Angina pectoris	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Cardiac disorders Tachycardia	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Eye disorders Erythema of eyelid	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Eye disorders Eye pain	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Eye disorders Periorbital swelling	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Gastrointestinal disorders Aphthous ulcer	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
General disorders Injection site induration	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
General disorders Injection site pruritus	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
General disorders Pain	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Infections and infestations Gastroenteritis	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Injury, poisoning and procedural complications Expired product administered	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Investigations Weight decreased	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	18.2% 6/33 • Number of events 6 • From Baseline to approximately 4.5 years Safety Population
Nervous system disorders Disturbance in attention	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Nervous system disorders Seizure	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	6.1% 2/33 • Number of events 2 • From Baseline to approximately 4.5 years Safety Population
Psychiatric disorders Insomnia	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Psychiatric disorders Mood altered	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	3.0% 1/33 • Number of events 1 • From Baseline to approximately 4.5 years Safety Population
Skin and subcutaneous tissue disorders Erythema	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/33 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/101 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/49 • From Baseline to approximately 4.5 years Safety Population	0.00% 0/10 • From Baseline to approximately 4.5 years Safety Population	9.1% 3/33 • Number of events 3 • From Baseline to approximately 4.5 years Safety Population

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: 61 6878333

Email: global.trial_information@roche.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER