Trial Outcomes & Findings for A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (NCT NCT01685203)

Last Updated: 2021-07-30

Results Overview

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\<LLOQ\]) 12 weeks after the last dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

316 participants

Primary outcome timeframe

12 weeks after the last actual dose of study drug

Results posted on

2021-07-30

Participant Flow

The study originally planned to enroll Group 5 (GT4 treatment-experienced, 2-DAA regimen for 12 weeks), but based on a protocol-specified interim review of results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher SVR rates among participants receiving the 2-DAA regimen with RBV, Group 5 was not opened to enrollment.

Participant milestones

Participant milestones
Measure	Group 1 ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 2 ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants	Group 3 ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants	Group 4 ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 6 ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants	Group 7 ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis	Group 8 ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Overall Study STARTED	44	42	40	42	49	47	52
Overall Study Completed Study Drug	42	40	39	42	49	43	52
Overall Study COMPLETED	40	39	40	41	49	44	52
Overall Study NOT COMPLETED	4	3	0	1	0	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 2 ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants	Group 4 ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 7 ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
Overall Study Lost to Follow-up	3	3	1	0
Overall Study Adverse Event	0	0	0	2
Overall Study Adverse event and withdrew consent	1	0	0	0
Overall Study Patient's decision	0	0	0	1

Baseline Characteristics

A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=44 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 2 n=42 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants	Group 3 n=40 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants	Group 4 n=42 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 6 n=49 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants	Group 7 n=47 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis	Group 8 n=52 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis	Total n=316 Participants Total of all reporting groups
Age, Continuous	48.9 years STANDARD_DEVIATION 10.0 • n=5 Participants	55.8 years STANDARD_DEVIATION 6.9 • n=7 Participants	54.2 years STANDARD_DEVIATION 9.6 • n=5 Participants	44.2 years STANDARD_DEVIATION 12.7 • n=4 Participants	50.9 years STANDARD_DEVIATION 10.1 • n=21 Participants	57.8 years STANDARD_DEVIATION 7.1 • n=10 Participants	57.1 years STANDARD_DEVIATION 6.0 • n=115 Participants	52.8 years STANDARD_DEVIATION 10.1 • n=6 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	17 Participants n=7 Participants	25 Participants n=5 Participants	14 Participants n=4 Participants	13 Participants n=21 Participants	24 Participants n=10 Participants	19 Participants n=115 Participants	132 Participants n=6 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	25 Participants n=7 Participants	15 Participants n=5 Participants	28 Participants n=4 Participants	36 Participants n=21 Participants	23 Participants n=10 Participants	33 Participants n=115 Participants	184 Participants n=6 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: All randomized participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Group 1 n=44 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 2 n=42 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants	Group 3 n=40 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants	Group 4 n=42 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 6 n=49 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants	Group 7 n=47 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis	Group 8 n=52 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment	90.9 Percentage of participants Interval 78.3 to 97.5	95.2 Percentage of participants Interval 83.8 to 99.4	90.0 Percentage of participants Interval 76.3 to 97.2	100 Percentage of participants Interval 91.6 to 100.0	100 Percentage of participants Interval 92.7 to 100.0	97.9 Percentage of participants Interval 88.7 to 99.9	98.1 Percentage of participants Interval 89.7 to 100.0

SECONDARY outcome

Timeframe: 24 weeks after the last actual dose of study drug

Population: All randomized participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Group 1 n=44 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 2 n=42 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants	Group 3 n=40 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants	Group 4 n=42 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 6 n=49 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants	Group 7 n=47 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis	Group 8 n=52 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment	86.4 Percentage of participants Interval 72.6 to 94.8	92.9 Percentage of participants Interval 80.5 to 98.5	90.0 Percentage of participants Interval 76.3 to 97.2	100.0 Percentage of participants Interval 91.6 to 100.0	100.0 Percentage of participants Interval 92.7 to 100.0	97.9 Percentage of participants Interval 88.7 to 99.9	98.1 Percentage of participants Interval 89.7 to 100.0

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8

Population: All randomized participants who received at least 1 dose of study drug.

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \[≥ LLOQ\] after HCV RNA \< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \[2 consecutive HCV RNA measurements \> 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline\] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment).

Outcome measures

Outcome measures
Measure	Group 1 n=44 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 2 n=42 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants	Group 3 n=40 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants	Group 4 n=42 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 6 n=49 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants	Group 7 n=47 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis	Group 8 n=52 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.	2.3 Percentage of participants Interval 0.1 to 12.0	0 Percentage of participants Interval 0.0 to 8.4	2.5 Percentage of participants Interval 0.1 to 13.2	0 Percentage of participants Interval 0.0 to 8.4	0 Percentage of participants Interval 0.0 to 7.3	0 Percentage of participants Interval 0.0 to 7.5	0 Percentage of participants Interval 0.0 to 6.8

SECONDARY outcome

Timeframe: Within 12 weeks after the last dose of study drug

Population: All randomized participants who received at least 1 dose of study drug and completed treatment with HCV RNA \< LLOQ at the final treatment visit.

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA \< LLOQ at the end of treatment.

Outcome measures

Outcome measures
Measure	Group 1 n=42 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 2 n=40 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants	Group 3 n=39 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants	Group 4 n=42 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 6 n=49 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants	Group 7 n=44 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis	Group 8 n=52 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.	4.8 Percentage of participants Interval 0.6 to 16.2	0 Percentage of participants Interval 0.0 to 8.8	7.7 Percentage of participants Interval 1.6 to 20.9	0 Percentage of participants Interval 0.0 to 8.4	0 Percentage of participants Interval 0.0 to 7.3	0 Percentage of participants Interval 0.0 to 8.0	1.9 Percentage of participants Interval 0.0 to 10.3

SECONDARY outcome

Timeframe: From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.

Population: All randomized participants who received at least 1 dose of study drug.

Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.

Outcome measures

Outcome measures
Measure	Group 1 n=44 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 2 n=42 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants	Group 3 n=40 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants	Group 4 n=42 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 6 n=49 Participants ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants	Group 7 n=47 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis	Group 8 n=52 Participants ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events	77.3 Percentage of participants	73.8 Percentage of participants	80.0 Percentage of participants	88.1 Percentage of participants	85.7 Percentage of participants	85.1 Percentage of participants	71.2 Percentage of participants

Adverse Events

Group 1

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Group 2

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Group 3

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Group 4

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Group 6

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Group 7

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Group 8

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=44 participants at risk ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 2 n=42 participants at risk ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants	Group 3 n=40 participants at risk ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants	Group 4 n=42 participants at risk ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 6 n=49 participants at risk ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/ RBV (pegIFN/RBV) treatment-experienced participants	Group 7 n=47 participants at risk ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis	Group 8 n=52 participants at risk ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/ RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Cardiac disorders ATRIAL FIBRILLATION	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Gastrointestinal disorders OESOPHAGEAL VARICES HAEMORRHAGE	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
General disorders DEVICE EXTRUSION	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.5% 1/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Injury, poisoning and procedural complications CONTUSION	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC NEOPLASM	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Nervous system disorders PARTIAL SEIZURES	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Vascular disorders PERIPHERAL ARTERY ANEURYSM	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.

Other adverse events

Other adverse events
Measure	Group 1 n=44 participants at risk ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 2 n=42 participants at risk ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants	Group 3 n=40 participants at risk ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants	Group 4 n=42 participants at risk ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants	Group 6 n=49 participants at risk ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/ RBV (pegIFN/RBV) treatment-experienced participants	Group 7 n=47 participants at risk ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis	Group 8 n=52 participants at risk ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/ RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Cardiac disorders TACHYCARDIA	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.4% 3/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Ear and labyrinth disorders VERTIGO	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	7.1% 3/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.5% 1/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.3% 2/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.0% 1/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.4% 3/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.0% 1/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	7.7% 4/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Gastrointestinal disorders DIARRHOEA	4.5% 2/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	14.3% 6/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	14.3% 6/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.1% 3/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	14.9% 7/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	13.5% 7/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Gastrointestinal disorders DYSPEPSIA	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	8.2% 4/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Gastrointestinal disorders FLATULENCE	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.8% 3/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Gastrointestinal disorders NAUSEA	9.1% 4/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	19.0% 8/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	16.7% 7/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	12.2% 6/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	10.6% 5/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	9.6% 5/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Gastrointestinal disorders VOMITING	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	7.1% 3/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.3% 2/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
General disorders ASTHENIA	25.0% 11/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	7.1% 3/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	23.8% 10/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	32.7% 16/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	21.3% 10/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	13.5% 7/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
General disorders FATIGUE	6.8% 3/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	14.3% 6/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	11.9% 5/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	18.4% 9/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	8.5% 4/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	11.5% 6/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.0% 1/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	3.8% 2/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
General disorders IRRITABILITY	6.8% 3/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	14.3% 6/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.1% 2/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
General disorders OEDEMA PERIPHERAL	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	7.1% 3/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.1% 2/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.3% 2/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	3.8% 2/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
General disorders PYREXIA	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.1% 3/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Infections and infestations BRONCHITIS	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.5% 1/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.1% 2/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.4% 3/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Infections and infestations GASTROENTERITIS	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Infections and infestations INFLUENZA	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.1% 2/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	3.8% 2/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Infections and infestations NASOPHARYNGITIS	4.5% 2/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	12.2% 6/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	8.5% 4/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	7.7% 4/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Infections and infestations RHINITIS	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.1% 3/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.0% 1/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.3% 2/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	7.7% 4/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Infections and infestations URINARY TRACT INFECTION	6.8% 3/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.1% 2/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.3% 2/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Investigations BLOOD PRESSURE INCREASED	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Metabolism and nutrition disorders DECREASED APPETITE	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.1% 3/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.3% 2/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Metabolism and nutrition disorders INCREASED APPETITE	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.4% 3/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.0% 1/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	8.5% 4/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Musculoskeletal and connective tissue disorders BACK PAIN	6.8% 3/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	8.2% 4/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	12.8% 6/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	9.6% 5/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	10.2% 5/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.4% 3/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	3.8% 2/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Nervous system disorders DIZZINESS	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	7.5% 3/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.1% 3/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Nervous system disorders HEADACHE	29.5% 13/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	33.3% 14/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	25.0% 10/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	33.3% 14/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	28.6% 14/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	19.1% 9/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	19.2% 10/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Psychiatric disorders ANXIETY	4.5% 2/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	9.5% 4/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.1% 2/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	3.8% 2/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Psychiatric disorders DEPRESSION	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.1% 3/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Psychiatric disorders INSOMNIA	4.5% 2/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	9.5% 4/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	16.3% 8/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.4% 3/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	7.7% 4/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	8.2% 4/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.4% 3/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	9.6% 5/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.8% 2/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.1% 3/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	2.3% 1/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.0% 2/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.0% 1/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	4.3% 2/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	5.8% 3/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	16.7% 7/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	6.1% 3/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.1% 1/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Skin and subcutaneous tissue disorders PRURITUS	4.5% 2/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	14.3% 6/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	10.2% 5/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	17.0% 8/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	17.3% 9/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.
Vascular disorders HYPERTENSION	0.00% 0/44 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	0.00% 0/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.5% 1/40 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.4% 1/42 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	2.0% 1/49 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	14.9% 7/47 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.	1.9% 1/52 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8. Serious adverse events were collected from the time of informed consent until the end of participation, up to 65 weeks.

Additional Information

Global Medical Information

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER