Trial Outcomes & Findings for Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807) (NCT NCT00537316)

NCT ID: NCT00537316

Last Updated: 2017-04-12

Results Overview

Steroid-free remission is defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point, without the use of corticosteroids. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician's global assessment.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 242 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2017-04-12

Participant Flow

2 participants were randomized but not treated. Part 1: 237 participants received ≥1 dose study medication. Part 2: Of 108 enrolled/randomized participants, 95 continued assigned treatment from Part 1 and 13 were randomized and entered into Part 2 of the study (10 participants from Part 1 and 3 participants who were enrolled directly into Part 2).

Participant milestones

Measure	Infliximab (IFX) IFX 5 mg/kg Intravenous (IV) infusions administered at Weeks 0, 2, and 6 and placebo to AZA (orally) daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.	Azathioprine (AZA) AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one placebo IFX infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive IFX at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.	IFX/AZA IFX 5 mg/kg IV infusion at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks. Responders to IFX/AZA at Week 8 will receive one more IFX infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14.	Maintenance IFX/AZA (During Part 2) Participants randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).	Maintenance IFX (During Part 2) Participants randomized to maintenance IFX received infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) and placebo to AZA therapy as allocated in Part 1 of the study (all participants were from Part 1 of the study).	Intermittent IFX/AZA (During Part 2) Participants randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).	Intermittent IFX (During Part 2) Participants randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA as allocated in Part 1 of the study (1 participant from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
Part 1 STARTED	79	80	80	0	0	0	0
Part 1 COMPLETED	65	53	63	0	0	0	0
Part 1 NOT COMPLETED	14	27	17	0	0	0	0
Part 2 STARTED	37	10	48	5	2	4	2
Part 2 COMPLETED	11	1	16	2	1	0	0
Part 2 NOT COMPLETED	26	9	32	3	1	4	2

Reasons for withdrawal

Measure	Infliximab (IFX) IFX 5 mg/kg Intravenous (IV) infusions administered at Weeks 0, 2, and 6 and placebo to AZA (orally) daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.	Azathioprine (AZA) AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one placebo IFX infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive IFX at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.	IFX/AZA IFX 5 mg/kg IV infusion at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks. Responders to IFX/AZA at Week 8 will receive one more IFX infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14.	Maintenance IFX/AZA (During Part 2) Participants randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).	Maintenance IFX (During Part 2) Participants randomized to maintenance IFX received infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) and placebo to AZA therapy as allocated in Part 1 of the study (all participants were from Part 1 of the study).	Intermittent IFX/AZA (During Part 2) Participants randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).	Intermittent IFX (During Part 2) Participants randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA as allocated in Part 1 of the study (1 participant from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
Part 1 Adverse Event	7	11	8	0	0	0	0
Part 1 Protocol defined clinical event	1	0	0	0	0	0	0
Part 1 Lost to Follow-up	1	0	0	0	0	0	0
Part 1 Withdrawal by Subject	3	8	4	0	0	0	0
Part 1 Protocol Violation	1	5	1	0	0	0	0
Part 1 Did not meet protocol eligibility	1	3	2	0	0	0	0
Part 1 Administrative	0	0	2	0	0	0	0
Part 2 Never entered follow-up	0	0	0	0	0	0	1
Part 2 Adverse Event	4	0	2	0	0	0	0
Part 2 Lost to Follow-up	1	0	2	0	0	0	0
Part 2 Withdrawal by Subject	5	1	4	0	0	0	0
Part 2 Administrative	16	8	24	3	1	4	1

Baseline Characteristics

Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)

Baseline characteristics by cohort

Measure	Infliximab (IFX) n=78 Participants All treated participants. IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.	Azathioprine (AZA) n=79 Participants All treated participants. AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.	IFX/AZA n=80 Participants All treated participants. IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks. Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14.	Maintenance IFX/AZA (During Part 2) n=1 Participants Participants enrolled directly and randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).	Intermittent IFX/AZA (During Part 2) n=1 Participants Participants enrolled directly and randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).	Intermittent IFX (During Part 2) n=1 Participants Participants enrolled directly and randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA daily in Part 2 of the study (1 participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).	Total n=240 Participants Total of all reporting groups
Age, Customized <18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Customized 18 years to <65 years	77 Participants n=5 Participants	76 Participants n=7 Participants	78 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	234 Participants n=115 Participants
Age, Customized 65 years and older	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	46 Participants n=7 Participants	32 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	116 Participants n=115 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	33 Participants n=7 Participants	48 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	124 Participants n=115 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation). Participants who dropped out prior to Week 16, had a missing Mayo score at Week 16, or were non-responders at Week 8 are considered failures (non-remission) at Week 16.

Steroid-free remission is defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point, without the use of corticosteroids. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician's global assessment.

Outcome measures

Measure	Infliximab (IFX) n=77 Participants IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.	Azathioprine (AZA) n=76 Participants AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.	IFX/AZA n=78 Participants IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks. Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14.
Proportion of Participants in Steroid-free Remission at Week 16	0.22 Proportion of participants	0.24 Proportion of participants	0.40 Proportion of participants

PRIMARY outcome

Timeframe: up to Week 94 (Week 78 for direct entry)

Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study (Week 38 through Week 94 [Week 22 through Week 78 for direct entry]).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 8 and 16

Population: Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation). Participants who dropped out prior to Week 16, had a missing Mayo score at Week 16, or were non-responders at Week 8 are considered failures (non-responders) at Week 16.

Response at Week 8 is defined as a decrease in the partial Mayo score of ≥1 point. Response at Week 16 is defined as a decrease in total Mayo score of ≥3 points and at least 30% lower than baseline Mayo score. The partial Mayo score consists of the following 3 sub-scores: stool frequency, rectal bleeding, and physician's global assessment. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician's global assessment.

Outcome measures

Measure	Infliximab (IFX) n=77 Participants IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.	Azathioprine (AZA) n=76 Participants AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.	IFX/AZA n=78 Participants IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks. Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14.
Proportion of Participants in Response at Weeks 8 and 16 Week 8	0.88 Proportion of participants	0.66 Proportion of participants	0.86 Proportion of participants
Proportion of Participants in Response at Weeks 8 and 16 Week 16	0.69 Proportion of participants	0.50 Proportion of participants	0.77 Proportion of participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation).

Mucosal healing was defined as a Mayo endoscopy score of 0 or 1.

Outcome measures

Measure	Infliximab (IFX) n=77 Participants IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.	Azathioprine (AZA) n=76 Participants AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.	IFX/AZA n=78 Participants IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks. Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14.
Proportion of Participants With Mucosal Healing at Week 16	0.55 Proportion of participants	0.37 Proportion of participants	0.63 Proportion of participants

SECONDARY outcome

Timeframe: Weeks 38, 62 & 94 (Weeks 22, 46 and 78 for direct entry)

Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 38, 62 and 94 (Weeks 22, 46 and 78 for direct entry)

Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study

Outcome measures

Outcome data not reported

Adverse Events

AZA Through Week 8

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

IFX/AZA Through Week 8

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

IFX Through Week 8

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

AZA After Week 8

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

AZA to IFX/AZA After Week 8

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

IFX/AZA After Week 8

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

IFX After Week 8

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Maintenance IFX/AZA (Part 2)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Maintenance IFX (Part 2)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Intermittent IFX/AZA (Part 2)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Intermittent IFX (Part 2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AZA (Part 2)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

IFX/AZA (Part 2)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

IFX (Part 2)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	AZA Through Week 8 n=79 participants at risk Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.	IFX/AZA Through Week 8 n=80 participants at risk Participants received intravenous (IV) infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks. Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14.	IFX Through Week 8 n=78 participants at risk Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.	AZA After Week 8 n=42 participants at risk Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.	AZA to IFX/AZA After Week 8 n=20 participants at risk Participants received AZA 2.5 mg/kg orally for 16 weeks and had IV infusions of IFX 5mg/kg of body weight added to their treatment regimen at Weeks 8, 10, and 14. Participants were either non-responders to AZA at Week 8 or had worsening of disease at Week 8.	IFX/AZA After Week 8 n=72 participants at risk Participants received IV infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks. Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14.	IFX After Week 8 n=74 participants at risk Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.	Maintenance IFX/AZA (Part 2) n=5 participants at risk Participants randomized to maintenance IFX/AZA during Part 2 received IV infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily. Four participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.	Maintenance IFX (Part 2) n=2 participants at risk Participants randomized to maintenance IFX received IV infusions of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry). All participants were from Part 1 of the study.	Intermittent IFX/AZA (Part 2) n=4 participants at risk Participants randomized to intermittent IFX/AZA received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily. Three participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.	Intermittent IFX (Part 2) n=2 participants at risk Participants randomized to intermittent IFX received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained). One participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.	AZA (Part 2) n=10 participants at risk Participants received AZA 2.5 mg/kg of body weight orally daily for Part 2 of the study. All participants were from Part 1 of the study.	IFX/AZA (Part 2) n=48 participants at risk Participants received IV infusions of IFX 5 mg/kg of body weight every 8 weeks and AZA 2.5 mg/kg of body weight orally daily until the end of the study. All participants were from Part 1 of the study.	IFX (Part 2) n=37 participants at risk Participants received IV infusions of IFX 5 mg/kg of body weight until the end of the study. All participants were from Part 1 of the study.
Gastrointestinal disorders Intestinal Haemorrhage	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Gastrointestinal disorders Abdominal Pain Upper	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Gastrointestinal disorders Colitis Ulcerative	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.5% 2/80 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	4.1% 3/74 • Number of events 3 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Blood and lymphatic system disorders Anaemia	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Gastrointestinal disorders Pancreatitis acute	2.5% 2/79 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Gastrointestinal disorders Vomiting	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
General disorders Disease Progression	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
General disorders Drug Ineffective	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
General disorders Hyperthermia	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
General disorders Pyrexia	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Infections and infestations Amoebiasis	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Infections and infestations Aspergillosis	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	5.0% 1/20 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Infections and infestations Pneumonia	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Metabolism and nutrition disorders Dehydration	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Skin and subcutaneous tissue disorders Rash	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Surgical and medical procedures Ileostomy closure	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Surgical and medical procedures Intestinal Anastomosis	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Surgical and medical procedures Proctocolectomy	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Vascular disorders Thrombophlebitis	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Vascular disorders Vasculitis	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)

Other adverse events

Measure	AZA Through Week 8 n=79 participants at risk Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.	IFX/AZA Through Week 8 n=80 participants at risk Participants received intravenous (IV) infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks. Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14.	IFX Through Week 8 n=78 participants at risk Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.	AZA After Week 8 n=42 participants at risk Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.	AZA to IFX/AZA After Week 8 n=20 participants at risk Participants received AZA 2.5 mg/kg orally for 16 weeks and had IV infusions of IFX 5mg/kg of body weight added to their treatment regimen at Weeks 8, 10, and 14. Participants were either non-responders to AZA at Week 8 or had worsening of disease at Week 8.	IFX/AZA After Week 8 n=72 participants at risk Participants received IV infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks. Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14.	IFX After Week 8 n=74 participants at risk Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.	Maintenance IFX/AZA (Part 2) n=5 participants at risk Participants randomized to maintenance IFX/AZA during Part 2 received IV infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily. Four participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.	Maintenance IFX (Part 2) n=2 participants at risk Participants randomized to maintenance IFX received IV infusions of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry). All participants were from Part 1 of the study.	Intermittent IFX/AZA (Part 2) n=4 participants at risk Participants randomized to intermittent IFX/AZA received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily. Three participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.	Intermittent IFX (Part 2) n=2 participants at risk Participants randomized to intermittent IFX received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained). One participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.	AZA (Part 2) n=10 participants at risk Participants received AZA 2.5 mg/kg of body weight orally daily for Part 2 of the study. All participants were from Part 1 of the study.	IFX/AZA (Part 2) n=48 participants at risk Participants received IV infusions of IFX 5 mg/kg of body weight every 8 weeks and AZA 2.5 mg/kg of body weight orally daily until the end of the study. All participants were from Part 1 of the study.	IFX (Part 2) n=37 participants at risk Participants received IV infusions of IFX 5 mg/kg of body weight until the end of the study. All participants were from Part 1 of the study.
Blood and lymphatic system disorders Anaemia	5.1% 4/79 • Number of events 4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	3.8% 3/78 • Number of events 3 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.4% 1/42 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/72 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Blood and lymphatic system disorders Iron deficiency anemia	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Endocrine disorders Hypothyroidism	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	20.0% 1/5 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Gastrointestinal disorders Abdominal pain	7.6% 6/79 • Number of events 6 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	6.4% 5/78 • Number of events 10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Gastrointestinal disorders Colitis Ulcerative	2.5% 2/79 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	5.0% 1/20 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	4.2% 3/72 • Number of events 3 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.1% 1/48 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	5.4% 2/37 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Gastrointestinal disorders Flatulence	5.1% 4/79 • Number of events 9 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.4% 1/42 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Gastrointestinal disorders Nausea	12.7% 10/79 • Number of events 15 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	10.0% 8/80 • Number of events 10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.8% 2/72 • Number of events 4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Gastrointestinal disorders Vomiting	7.6% 6/79 • Number of events 8 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/72 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 3 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
General disorders Fatigue	6.3% 5/79 • Number of events 5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.4% 1/42 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.1% 1/48 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
General disorders Pyrexia	3.8% 3/79 • Number of events 5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	6.4% 5/78 • Number of events 5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	5.0% 1/20 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 2/74 • Number of events 3 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	4.2% 2/48 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Infections and infestations Bronchitis	2.5% 2/79 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/72 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	20.0% 1/5 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Infections and infestations Ear infection	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	50.0% 1/2 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Infections and infestations Gastroenteritis	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	25.0% 1/4 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Infections and infestations Nasopharyngitis	3.8% 3/79 • Number of events 7 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.4% 1/42 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	5.0% 1/20 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/72 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	8.3% 4/48 • Number of events 5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	5.4% 2/37 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Infections and infestations Pharyngitis	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	50.0% 1/2 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Investigations Haemoglobin decreased	1.3% 1/79 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	20.0% 1/5 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Investigations White blood cell count decreased	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/80 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.4% 1/42 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/72 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	50.0% 1/2 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.1% 1/48 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 2/79 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	3.8% 3/80 • Number of events 7 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	7.1% 3/42 • Number of events 4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.8% 2/72 • Number of events 4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 2/74 • Number of events 4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Musculoskeletal and connective tissue disorders Back pain	2.5% 2/79 • Number of events 5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.3% 1/78 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.4% 1/42 • Number of events 4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/74 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	10.0% 1/10 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.1% 1/48 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Nervous system disorders Dysgeusia	0.00% 0/79 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/78 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.4% 1/72 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	20.0% 1/5 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/48 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/37 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Nervous system disorders Headache	10.1% 8/79 • Number of events 13 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	6.2% 5/80 • Number of events 8 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	5.1% 4/78 • Number of events 7 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.4% 1/42 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.8% 2/72 • Number of events 5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 2/74 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/5 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	4.2% 2/48 • Number of events 3 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)
Skin and subcutaneous tissue disorders Rash	2.5% 2/79 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	1.2% 1/80 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.6% 2/78 • Number of events 2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/42 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/20 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/72 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/74 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	20.0% 1/5 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/4 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/2 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	0.00% 0/10 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.1% 1/48 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)	2.7% 1/37 • Number of events 1 • Adverse events (AEs) were categorized by 3 separate timeframes: Through Week 8 (AEs reported through Week 8 of Part 1), After Week 8 (AEs reported after Week 8 through Week 16 of Part 1), and Part 2 (AEs reported during Part 2)

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and sponsor's representative will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
• Publication restrictions are in place

Restriction type: OTHER