Trial Outcomes & Findings for A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors (NCT NCT02784795)

Last Updated: 2025-08-21

Results Overview

DLT is defined as an adverse event (AE) during Cycle 1 (28 days for Part A, B and C and 21 days for Part D, E) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

94 participants

Primary outcome timeframe

Baseline to toxicity (up to end of Cycle 1 [1Cycle = 28 days for Part A, B and C and 21 days for Part D, E])

Results posted on

2025-08-21

Participant Flow

The study consists of 5 separate, parallel dose escalations (dose esc) followed by dose-confirmation (dose conf) study parts (Part A - E). LY3039478 is given in combination with taladegib for Part A, LY3023414 for Part B, abemaciclib (abema) for Part C, cisplatin (cis) and gemcitabine (gem) for Part C, and gemcitabine and carboplatin (carb) for Part E. A participant completed the study if they completed at least 1 cycle (1 cycle = 28 days for Part A, B and C and 21 days for Part D, E) .

Participant milestones

Participant milestones
Measure	Part A:25 Milligram(mg) LY3039478+200 mg Taladegib(Cohort 1) 25 mg LY3039478 given orally 3 times per week (TIW) in combination with 200 mg taladegib given orally once daily (QD) on a 28 day cycle. A single dose of 200 mg taladegib was also be given on day 1 during a 3-day lead-in period for pharmacokinetic (PK) evaluation. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 200 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 150 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
Overall Study STARTED	8	5	4	5	18	3	12	8	6	10	5	10
Overall Study Received at Least One Dose of Study Drug	8	5	4	5	18	3	12	8	6	10	5	10
Overall Study Completed at Least 1 Treatment Cycle	8	5	4	5	18	3	12	8	6	10	5	10
Overall Study COMPLETED	4	4	1	3	12	3	8	7	6	10	4	6
Overall Study NOT COMPLETED	4	1	3	2	6	0	4	1	0	0	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A:25 Milligram(mg) LY3039478+200 mg Taladegib(Cohort 1) 25 mg LY3039478 given orally 3 times per week (TIW) in combination with 200 mg taladegib given orally once daily (QD) on a 28 day cycle. A single dose of 200 mg taladegib was also be given on day 1 during a 3-day lead-in period for pharmacokinetic (PK) evaluation. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 200 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 150 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation. Participants receiving benefit may continue until disease progression.	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
Overall Study Progressive Disease	2	1	1	0	2	2	0	1	0
Overall Study Adverse Event	1	0	0	1	0	1	0	0	2
Overall Study Withdrawal by Subject	1	0	2	1	3	0	1	0	2
Overall Study Death	0	0	0	0	1	0	0	0	0
Overall Study Physician Decision	0	0	0	0	0	1	0	0	0

Baseline Characteristics

A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=8 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) n=5 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) n=4 Participants 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) n=5 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) n=18 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) n=3 Participants 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) n=12 Participants 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) n=8 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) n=6 Participants 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) n=10 Participants 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) n=5 Participants 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) n=10 Participants 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Total n=94 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 16.8 • n=5 Participants	53.0 years STANDARD_DEVIATION 8.5 • n=7 Participants	62.3 years STANDARD_DEVIATION 3.9 • n=5 Participants	56.6 years STANDARD_DEVIATION 11.8 • n=4 Participants	47.2 years STANDARD_DEVIATION 13.4 • n=21 Participants	60.0 years STANDARD_DEVIATION 11.8 • n=10 Participants	54.3 years STANDARD_DEVIATION 11.4 • n=115 Participants	51.1 years STANDARD_DEVIATION 13.9 • n=24 Participants	59.7 years STANDARD_DEVIATION 8.6 • n=42 Participants	52.6 years STANDARD_DEVIATION 12.9 • n=42 Participants	62.8 years STANDARD_DEVIATION 6.8 • n=42 Participants	53.6 years STANDARD_DEVIATION 12.2 • n=42 Participants	54.0 years STANDARD_DEVIATION 12.43 • n=36 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants	2 Participants n=10 Participants	8 Participants n=115 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	5 Participants n=42 Participants	4 Participants n=42 Participants	8 Participants n=42 Participants	54 Participants n=36 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	1 Participants n=10 Participants	4 Participants n=115 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	5 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	40 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	10 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	13 Participants n=21 Participants	3 Participants n=10 Participants	11 Participants n=115 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	9 Participants n=42 Participants	5 Participants n=42 Participants	7 Participants n=42 Participants	78 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	6 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	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	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=36 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	13 Participants n=21 Participants	3 Participants n=10 Participants	11 Participants n=115 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	9 Participants n=42 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	78 Participants n=36 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	7 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=36 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants	0 Participants n=10 Participants	7 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants	34 Participants n=36 Participants
Region of Enrollment Denmark	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Region of Enrollment France	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	6 Participants n=42 Participants	3 Participants n=42 Participants	5 Participants n=42 Participants	36 Participants n=36 Participants
Region of Enrollment Spain	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	4 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	23 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline to toxicity (up to end of Cycle 1 [1Cycle = 28 days for Part A, B and C and 21 days for Part D, E])

Population: All participants who receive at least one dose of study drug in Part A, B, C, D and E.

Outcome measures

Outcome measures
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=8 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) n=5 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) n=4 Participants 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) n=5 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) n=18 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) n=3 Participants 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) n=12 Participants 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) n=8 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) n=6 Participants 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) n=10 Participants 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) n=5 Participants 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) n=10 Participants 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
Number of Participants With LY3039478 Dose-Limiting Toxicities (DLT) in Part A, B, C, D and E	2 Participants	0 Participants	2 Participants	3 Participants	3 Participants	0 Participants	2 Participants	0 Participants	1 Participants	3 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Parts A/B/C Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30 hours post-dose; Parts D/E Day 1 (Cycle 1) and 15 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6-8, 24-30 hours post-dose

Population: All participants who received at least one dose of study drug with intensive PK sampling in the dose escalation cohorts of Part A, B, C, D and E. PK data was interpreted by combining Part B (25 mg LY3039478 + 150/200 mg LY3023414; Cohorts 1 and 3) and Part C (25 mg LY3039478 + 100/150 mg abemaciclib; Cohorts 1 and 3) reporting arms as all participants received same dose of 50 mg LY3039478 (Part B and C Cohorts 1 and 2) and to increase the sample size for interpretability.

AUC\[0-∞\] of LY3039478 in combination with taladegib, LY3023414, abemaciclib, cisplatin/gemcitabine, and gemcitabine/carboplatin in dose escalation parts of Part A, B, C, D and E was evaluated.

Outcome measures

Outcome measures
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=1 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) n=6 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) n=1 Participants 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) n=4 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) n=4 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) n=4 Participants 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) n=7 Participants 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) n=2 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) n=7 Participants 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 in Combination With Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin in Part A, B, C, D and E Day 1	—	—	—	—	—	1210 nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation 41	3080 nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation 35	NA nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation NA AUC\[0-∞\] could not be calculated for one participant in the "Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)" Arm for the Day 1	3400 nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation 70	—	—	—
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 in Combination With Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin in Part A, B, C, D and E Day 15	—	—	—	—	—	1030 nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation 9	NA nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 1980 ng\*h/mL.	NA nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual range = 804 -1400 ng\*h/mL.	NA nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual range = 3350 - 3620 ng\*h/mL.	—	—	—
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 in Combination With Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin in Part A, B, C, D and E Day 22	NA nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 295 ng\*h/mL.	2660 nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation 31	NA nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 4250 ng\*h/mL.	1820 nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation 44	5080 nanogramhour/mL (ngh/mL) Geometric Coefficient of Variation 12	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -3 (Lead in) : pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30, 72 hours post-dose and Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose

Population: All randomized participants who received at least one dose of study drug with evaluable PK data in Part A.

AUC\[0-∞\] of taladegib and its active metabolite LSN3185556, in combination with LY3039478 (Part A) was evaluated.

Outcome measures

Outcome measures
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=6 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
PK: AUC[0-∞] of Taladegib and Its Active Metabolite LSN3185556, in Combination With LY3039478 (Part A) Taladegib: Day -3	17100 ng*h/mL Geometric Coefficient of Variation 48	—	—	—	—	—	—	—	—	—	—	—
PK: AUC[0-∞] of Taladegib and Its Active Metabolite LSN3185556, in Combination With LY3039478 (Part A) Taladegib: Day 22	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 15400 ng\h/mL.	—	—	—	—	—	—	—	—	—	—	—
PK: AUC[0-∞] of Taladegib and Its Active Metabolite LSN3185556, in Combination With LY3039478 (Part A) LSN3185556 (Metabolite): Day -3	31900 ng*h/mL Geometric Coefficient of Variation 49	—	—	—	—	—	—	—	—	—	—	—
PK: AUC[0-∞] of Taladegib and Its Active Metabolite LSN3185556, in Combination With LY3039478 (Part A) LSN3185556 (Metabolite): Day 22	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 26400 ng\h/mL.	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -3 (Lead in): pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30, 72 hours post-dose

Population: All randomized participants who received at least one dose of study drug with evaluable PK data in Part B. Day -3 Cohort 1 and 2 results for Parts B were combined as 'Part B:150 mg LY3023414 (Cohort 1 and Cohort 2)' since they are from same dose and were collected in the absence of LY3039478 co-administration. Part B Cohort 4 participants had sparse PK sampling limited to day 22 so day -3 PK results are not available/reported.

AUC\[0-∞\] of LY3023414 in combination with LY3039478 (Part B) on day -3 was evaluated.

Outcome measures

Outcome measures
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=8 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) n=5 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
PK: AUC[0-∞] of LY3023414 in Combination With LY3039478 on Day -3 (Part B)	2620 ng*h/mL Geometric Coefficient of Variation 52	2780 ng*h/mL Geometric Coefficient of Variation 69	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose

Population: All participants who received at least one dose of study drug with intensive PK sampling in the dose escalation cohort of Part B

AUC\[0-∞\] of LY3023414 in combination with LY3039478 (Part B) on day 22 was evaluated. LY3023414 PK data is summarized only for dose escalation patients in Part B with intensive PK sampling.

Outcome measures

Outcome measures
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=4 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) n=1 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) n=2 Participants 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
PK: AUC[0-∞] of LY3023414 in Combination With LY3039478 on Day 22 (Part B)	2120 ng*h/mL Geometric Coefficient of Variation 50	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 2480 ng\h/mL.	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual range value = 2900 - 12000 ng\h/mL.	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day -3 (Lead in): pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30, 72 hours post-dose

Population: All randomized participants who received at least one dose of study drug with evaluable PK data in Part C. Day -3 Cohort 1 and 2 results for Parts B were combined as Part C: 100 mg Abemaciclib (Cohort 1 and Cohort 2) since they are from same dose and were collected in the absence of LY3039478 co-administration.

AUC\[0-∞\] of abemaciclib and AUC\[0-tlast\] of its major active metabolites LSN2839567 and LSN3106726, in combination with LY3039478 on Day 3 (Part C) was evaluated.

Outcome measures

Outcome measures
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=13 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) n=6 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day -3 (Part C) Abemaciclib	4570 ng*h/mL Geometric Coefficient of Variation 78	3240 ng*h/mL Geometric Coefficient of Variation 109	—	—	—	—	—	—	—	—	—	—
PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day -3 (Part C) LSN2839567 (Metabolite)	778 ng*h/mL Geometric Coefficient of Variation 65	663 ng*h/mL Geometric Coefficient of Variation 82	—	—	—	—	—	—	—	—	—	—
PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day -3 (Part C) LSN3106726 (Metabolite)	1700 ng*h/mL Geometric Coefficient of Variation 59	1510 ng*h/mL Geometric Coefficient of Variation 76	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose

Population: All randomized participants who received at least one dose of study drug with evaluable PK data in Part C.

AUC\[0-∞\] of abemaciclib and AUC\[0-tlast\] of its major active metabolites LSN2839567 and LSN3106726, in combination with LY3039478 on Day 22 (Part C) was evaluated.

Outcome measures

Outcome measures
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=3 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) n=2 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) n=1 Participants 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day 22 (Part C) LSN2839567 (Metabolite)	1460 ng*h/mL Geometric Coefficient of Variation 82	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 2130 ng\h/mL.	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 914 ng\h/mL.	—	—	—	—	—	—	—	—	—
PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day 22 (Part C) Abemaciclib	5270 ng*h/mL Geometric Coefficient of Variation 88	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual range value = 2510 - 6370 ng\h/mL.	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 3420 ng\h/mL.	—	—	—	—	—	—	—	—	—
PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day 22 (Part C) LSN3106726 (Metabolite)	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual range value = 2150 - 2690 ng\h/mL.	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 4120 ng\h/mL.	NA ngh/mL Geometric Coefficient of Variation NA Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 2590 ng\h/mL.	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression (Up To 12 Months)

Population: Duration of Response was not calculated for any participant as the study was terminated prior to data collection.

DoR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Objective Disease Progression or Death (Up To 1.91 Months for Part A, 7.69 Months for Part B, 11.53 Months for Part C, 19.52 Months for Part D, 7.03 Months for Part E)

Population: All randomized participants in Part A, B, C, D and E. Censored participants: Part A= 2, Part B = 0, 4, 2 and 7, Part C = 0, 6 and 5, Part D = 2, 3, Part E = 3, 7.

PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. PFS time was summarized using Kaplan-Meier estimates.

Outcome measures

Outcome measures
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=8 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) n=5 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) n=4 Participants 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) n=5 Participants 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) n=18 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) n=3 Participants 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) n=12 Participants 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) n=8 Participants 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) n=6 Participants 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) n=10 Participants 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) n=5 Participants 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) n=10 Participants 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
Progression Free Survival (PFS) Time in Part A, B, C, D and E	1.22 Months Interval 0.59 to 1.91	1.91 Months Interval 1.35 to 2.0	NA Months There were no events in Part B of Cohort 2.	1.91 Months Interval 1.87 to 7.69	1.84 Months Interval 0.92 to 3.68	1.94 Months Interval 1.61 to 11.53	1.91 Months Interval 1.38 to 5.72	NA Months Interval 1.74 to The upper limit of the 95% confidence Interval (CI) was not calculated due to the high censoring rate.	3.22 Months Interval 2.96 to The upper limit of the 95% confidence Interval (CI) was not calculated due to the high censoring rate.	3.02 Months Interval 1.15 to 3.48	6.00 Months Interval 4.96 to 7.03	4.71 Months Interval 3.06 to 6.21

Adverse Events

Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)

Serious events: 5 serious events

Other events: 7 other events

Deaths: 3 deaths

Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf)

Serious events: 9 serious events

Other events: 17 other events

Deaths: 9 deaths

Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)

Serious events: 9 serious events

Other events: 11 other events

Deaths: 1 deaths

Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 1 deaths

Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2)

Serious events: 7 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=8 participants at risk 25 mg LY3039478 given orally 3 times per week (TIW) in combination with 200 mg taladegib given orally once daily (QD) on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) n=5 participants at risk 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) n=4 participants at risk 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) n=5 participants at risk 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) n=18 participants at risk 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) n=3 participants at risk 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) n=12 participants at risk 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) n=8 participants at risk 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) n=6 participants at risk 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) n=10 participants at risk 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) n=5 participants at risk 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) n=10 participants at risk 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac failure congestive	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Ascites	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 4/12 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dysphagia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophagitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Umbilical hernia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	25.0% 2/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	30.0% 3/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chills	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Face oedema	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 2/12 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholangitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bacteraemia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Campylobacter colitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Device related infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Lung infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Alanine aminotransferase increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Platelet count decreased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Ataxia	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Memory impairment	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Presyncope	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypotension	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1) n=8 participants at risk 25 mg LY3039478 given orally 3 times per week (TIW) in combination with 200 mg taladegib given orally once daily (QD) on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc) n=5 participants at risk 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2) n=4 participants at risk 50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3) n=5 participants at risk 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf) n=18 participants at risk 25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1) n=3 participants at risk 25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2) n=12 participants at risk 50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3) n=8 participants at risk 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. Participants receiving benefit may continue until disease progression.	Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1) n=6 participants at risk 25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2) n=10 participants at risk 50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1) n=5 participants at risk 25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.	Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2) n=10 participants at risk 50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle. Participants receiving benefit may continue until disease progression.
Reproductive system and breast disorders Dyspareunia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vulval disorder	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Aspiration	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	22.2% 4/18 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 4/12 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 4/10 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 3/18 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 1/8 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	22.2% 4/18 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hair colour changes	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 2/12 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory symptom	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 3/12 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 2/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	30.0% 3/10 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 2/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hyperhidrosis	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Palmar erythema	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 2/12 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Palmoplantar keratoderma	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 4/8 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 4/12 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 3/5 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Embolism	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Haematoma	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypotension	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 3/5 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	22.2% 4/18 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	62.5% 5/8 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	83.3% 5/6 • Number of events 21 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 6/10 • Number of events 12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 4/5 • Number of events 23 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 6/10 • Number of events 25 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 2/8 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 3/6 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 4/10 • Number of events 16 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Pericardial effusion	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus tachycardia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Tachycardia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Deafness	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Keratitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Ear disorder	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Hypoacusis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Tinnitus	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hypothyroidism	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Blepharitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Dry eye	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	37.5% 3/8 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eye discharge	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eye pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eye pruritus	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eyelash discolouration	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eyelid oedema	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Lacrimation increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Photophobia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Vision blurred	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Vitreous floaters	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Xerophthalmia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 2/8 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Ascites	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Cheilitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colonic fistula	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	25.0% 2/8 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 4/5 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	75.0% 3/4 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	55.6% 10/18 • Number of events 16 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 16 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 8/12 • Number of events 13 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	75.0% 6/8 • Number of events 19 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	83.3% 5/6 • Number of events 20 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	70.0% 7/10 • Number of events 15 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 3/5 • Number of events 13 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	90.0% 9/10 • Number of events 25 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	22.2% 4/18 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	37.5% 3/8 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dysphagia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Flatulence	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 2/12 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	62.5% 5/8 • Number of events 10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 4/5 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 2/4 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 5/5 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	83.3% 15/18 • Number of events 22 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	58.3% 7/12 • Number of events 9 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 4/8 • Number of events 13 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 6/6 • Number of events 34 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	90.0% 9/10 • Number of events 20 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 4/5 • Number of events 11 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	70.0% 7/10 • Number of events 30 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Odynophagia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophageal pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oral pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Proctitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Stomatitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	38.9% 7/18 • Number of events 13 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 2/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Erysipelas	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	37.5% 3/8 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 4/5 • Number of events 11 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 2/4 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 4/5 • Number of events 10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	55.6% 10/18 • Number of events 15 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 3/12 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	87.5% 7/8 • Number of events 9 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	83.3% 5/6 • Number of events 14 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	70.0% 7/10 • Number of events 18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 4/5 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 4/10 • Number of events 19 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Asthenia	37.5% 3/8 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 3/18 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	37.5% 3/8 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	30.0% 3/10 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Axillary pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chills	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	25.0% 2/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 2/4 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 3/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	22.2% 4/18 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 4/12 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 4/8 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 4/6 • Number of events 14 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 5/10 • Number of events 13 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Feeling abnormal	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Gait disturbance	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders General physical health deterioration	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Malaise	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Mucosal dryness	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Mucosal inflammation	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 2/12 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Oedema peripheral	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 3/18 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Xerosis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bartholin's abscess	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Conjunctivitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 2/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Device related infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Folliculitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gingivitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Lung infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Nasopharyngitis	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Oral candidiasis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Paronychia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pharyngitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Respiratory tract infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sinusitis	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Skin infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tooth infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Vaginal infection	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Alanine aminotransferase increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	27.8% 5/18 • Number of events 11 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 3/12 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 4/6 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 5/10 • Number of events 12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 4/5 • Number of events 13 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 5/10 • Number of events 13 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Amylase increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	22.2% 4/18 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 3/12 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 3/6 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 4/10 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 4/5 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 6/10 • Number of events 13 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Bilirubin conjugated increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 2/12 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood bilirubin increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood creatinine increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	62.5% 5/8 • Number of events 9 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood culture positive	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood urea increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations C-reactive protein increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Gamma-glutamyltransferase increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 3/5 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations International normalised ratio increased	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Lipase increased	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Lymphocyte count decreased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 3/6 • Number of events 19 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Neutrophil count decreased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 4/6 • Number of events 13 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 4/10 • Number of events 11 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 4/5 • Number of events 15 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 4/10 • Number of events 15 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Nutritional condition abnormal	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Platelet count decreased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	83.3% 5/6 • Number of events 31 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	70.0% 7/10 • Number of events 25 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 3/5 • Number of events 14 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 5/10 • Number of events 30 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Transaminases increased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Weight decreased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 3/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 2/12 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 2/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Weight increased	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations White blood cell count decreased	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 3/6 • Number of events 15 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Appetite disorder	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	37.5% 3/8 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 2/4 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 3/5 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 6/18 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 3/12 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	62.5% 5/8 • Number of events 10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 4/6 • Number of events 12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	30.0% 3/10 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	30.0% 3/10 • Number of events 13 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypocalcaemia	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 2/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	25.0% 2/8 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 6/18 • Number of events 14 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 3/12 • Number of events 6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	37.5% 3/8 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 4/10 • Number of events 12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypomagnesaemia	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 4/10 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypophosphataemia	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 3/5 • Number of events 10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 2/4 • Number of events 5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	61.1% 11/18 • Number of events 14 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 7 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 4/12 • Number of events 17 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	62.5% 5/8 • Number of events 11 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	83.3% 5/6 • Number of events 47 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	70.0% 7/10 • Number of events 21 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 3/5 • Number of events 17 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	30.0% 3/10 • Number of events 12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hypoaesthesia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 3/18 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Aphasia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Aphonia	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cognitive disorder	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 2/8 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dysgeusia	25.0% 2/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 2/5 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Neuropathy peripheral	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Neurotoxicity	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Psychomotor skills impaired	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Seizure	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Somnolence	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Taste disorder	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Anxiety	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Confusional state	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depression	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Dermatillomania	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Insomnia	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 2/6 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Dysuria	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Glycosuria	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary incontinence	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Proteinuria	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal failure	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal impairment	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary retention	12.5% 1/8 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/18 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review and comment on results communications prior to public release and can embargo communications regarding trial results for a period that is more than 30 days but less than or equal to 90 days from the time the sponsor receives the publication for review. The sponsor can request that the PI hold publishing the communication in order to protect any intellectual property interest at stake.
Publication restrictions are in place

Restriction type: OTHER