Trial Outcomes & Findings for Investigation of GSK2879552 in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma (NCT NCT02034123)

NCT ID: NCT02034123

Last Updated: 2019-12-06

Results Overview

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on All Treated Population which included all participants who received at least one dose of study treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 29 participants
• Primary outcome timeframe: Median of 7.286 weeks of drug exposure
• Results posted on: 2019-12-06

Participant Flow

This was planned as a 2-part, first time in human study in participants with relapsed/refractory small cell lung carcinoma. Part 1 was a dose escalation cohort and Part 2 was an expansion cohort. Participants were planned to receive GSK2879552 at a starting dose of 0.25 milligrams (mg) once daily for 28 days.

This study was terminated early during Part 1 as the risk benefit in relapsed refractory SCLC did not favor continuation of the study. Data was collected only in Part 1 and no participants were enrolled in Part 2. A total of 29 participants enrolled and received treatment in Part 1. Of which 7 prematurely withdrawn and 22 completed study.

Participant milestones

Measure	Part 1:GSK2879552 0.25 mg Daily Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 1.0 mg Daily Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 1.5 mg Daily Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 2.0 mg Daily Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 3.0 mg Daily Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2:GSK2879552 0.25 mg Daily Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 0.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Part1(Median of 7.286 Weeks of Exposure) STARTED	1	1	5	3	7	3	2	5	2	0	0	0	0	0	0	0	0	0
Part1(Median of 7.286 Weeks of Exposure) COMPLETED	1	1	5	1	5	3	2	4	0	0	0	0	0	0	0	0	0	0
Part1(Median of 7.286 Weeks of Exposure) NOT COMPLETED	0	0	0	2	2	0	0	1	2	0	0	0	0	0	0	0	0	0
Part2(Up to 2 Years) STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part2(Up to 2 Years) COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part2(Up to 2 Years) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Measure	Part 1:GSK2879552 0.25 mg Daily Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 1.0 mg Daily Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 1.5 mg Daily Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 2.0 mg Daily Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 3.0 mg Daily Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2:GSK2879552 0.25 mg Daily Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 0.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Part1(Median of 7.286 Weeks of Exposure) Adverse Event	0	0	0	0	1	0	0	1	1	0	0	0	0	0	0	0	0	0
Part1(Median of 7.286 Weeks of Exposure) Lack of Efficacy	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part1(Median of 7.286 Weeks of Exposure) Other-Study closed/terminated	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Part1(Median of 7.286 Weeks of Exposure) Withdrawal by Subject	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Investigation of GSK2879552 in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma

Baseline characteristics by cohort

Measure	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 1.0 mg Daily n=5 Participants Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 1.5 mg Daily n=3 Participants Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 2.0 mg Daily n=7 Participants Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 3.0 mg Daily n=3 Participants Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2:GSK2879552 0.25 mg Daily Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 0.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Total n=29 Participants Total of all reporting groups
Age, Continuous	78.0 Years STANDARD_DEVIATION NA • n=93 Participants	47.0 Years STANDARD_DEVIATION NA • n=4 Participants	63.8 Years STANDARD_DEVIATION 4.09 • n=27 Participants	56.7 Years STANDARD_DEVIATION 8.08 • n=483 Participants	62.4 Years STANDARD_DEVIATION 7.41 • n=36 Participants	60.3 Years STANDARD_DEVIATION 7.51 • n=10 Participants	53.5 Years STANDARD_DEVIATION 13.44 • n=115 Participants	58.8 Years STANDARD_DEVIATION 10.33 • n=40 Participants	61.5 Years STANDARD_DEVIATION 9.19 • n=8 Participants	—	—	—	—	—	—	—	—	—	60.6 Years STANDARD_DEVIATION 8.58 • n=667 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=40 Participants	1 Participants n=8 Participants	—	—	—	—	—	—	—	—	—	11 Participants n=667 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants	3 Participants n=483 Participants	6 Participants n=36 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=40 Participants	1 Participants n=8 Participants	—	—	—	—	—	—	—	—	—	18 Participants n=667 Participants
Race/Ethnicity, Customized African American/African Heritage	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	—	—	—	—	—	—	—	—	—	1 Participants n=667 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	1 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants	3 Participants n=483 Participants	7 Participants n=36 Participants	3 Participants n=10 Participants	1 Participants n=115 Participants	5 Participants n=40 Participants	2 Participants n=8 Participants	—	—	—	—	—	—	—	—	—	28 Participants n=667 Participants

PRIMARY outcome

Timeframe: Median of 7.286 weeks of drug exposure

Population: All Treated Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on All Treated Population which included all participants who received at least one dose of study treatment.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs Any non-SAE	5 Participants	2 Participants	6 Participants	3 Participants	2 Participants	5 Participants	1 Participants	1 Participants	1 Participants
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs Any SAE	0 Participants	2 Participants	2 Participants	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Median of 7.286 weeks of drug exposure

Population: All Treated Population

An event was considered a DLT if it occurs within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event is unrelated to treatment: recurrent Grade 3 anemia after initial transfusion or Grade 3 anemia lasting > 7 days in participants who are not transfused, Grade 4 neutropenia, Grade 3 neutropenia > 7 days duration, febrile neutropenia as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Grade 3 thrombocytopenia requiring dose reduction, Grade 4 thrombocytopenia lasting > 3 days or of any duration if associated with clinically significant bleeding, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 2 toxicity (at any time during treatment) and treatment delay of 14 days or greater due to unresolved drug-related toxicity.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Number of Participants With Dose Limiting Toxicities (DLT)	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Median of 7.286 weeks of drug exposure

Population: All Treated Population

The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Number of Participants With Dose Reduction or Delays	0 Participants	0 Participants	3 Participants	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Median of 7.286 weeks of drug exposure

Population: All Treated Population

Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Number of Participants Withdrawn Due to Toxicities	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline and median of 7.286 weeks of drug exposure

Population: All Treated Population

Blood samples were collected for evaluation of clinical chemistry parameters including potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, alanine aminotransferase (ALT), uric acid, glucose, gamma glutamyl transferase (GGT), albumin, sodium, calcium, alkaline phosphatase, and phosphorus, inorganic. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in clinical chemistry parameters have been presented. The clinical chemistry parameters for which any grade increase worst-case on-therapy value was reported have been only summarized. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Albumin;n=1,1,5,3,5,3,2,5,2	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Alkaline Phosphatase;n=1,1,5,3,5,3,2,5,2	4 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline ALT;n=1,1,5,3,5,3,2,5,2	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline AST;n=1,1,5,3,5,3,2,5,2	3 Participants	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Total Bilirubin;n=1,1,5,3,5,3,2,5,2	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Calcium;n=1,1,5,3,5,3,2,5,2	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Calcium (hypercalcemia);n=1,1,5,3,5,3,2,5,2	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Calcium (hypocalcemia);n=1,1,5,3,5,3,2,5,2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Creatinine;n=1,1,5,3,5,3,2,5,2	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline GGT;n=1,1,5,3,5,3,2,5,2	4 Participants	1 Participants	2 Participants	3 Participants	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Glucose;n=1,1,5,3,6,3,2,5,2	2 Participants	1 Participants	4 Participants	1 Participants	1 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Glucose (hyperglycemia);n=1,1,5,3,6,3,2,5,2	2 Participants	1 Participants	4 Participants	1 Participants	1 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Glucose (hypoglycemia);n=1,1,5,3,6,3,2,5,2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Potassium;n=1,1,5,2,5,3,2,5,2	2 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Potassium (hyperkalemia);n=1,1,5,2,5,3,2,5,2	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Potassium (hypokalemia);n=1,1,5,2,5,3,2,5,2	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Sodium;n=1,1,5,3,5,3,2,5,2	3 Participants	0 Participants	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Sodium (hypernatremia);n=1,1,5,3,5,3,2,5,2	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Sodium (hyponatremia);n=1,1,5,3,5,3,2,5,2	3 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Phosphorus, inorganic;n=1,1,5,3,5,3,2,5,2	3 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline Uric acid;n=0,0,1,0,0,1,0,0,1	1 Participants	—	—	1 Participants	—	—	1 Participants	—	—

PRIMARY outcome

Timeframe: Baseline and median of 7.286 weeks of drug exposure

Population: All Treated Population. Only those participants with data available at specific time point were analyzed.

Blood samples were collected for the analysis of hematology parameters including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in hematology parameters have been presented. The hematology parameters for which any grade increase worst-case on-therapy value was reported have been only summarized.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=6 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline Hemoglobin	3 Participants	2 Participants	4 Participants	2 Participants	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline Hemoglobin (Increased)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline Hemoglobin (Anemia)	3 Participants	2 Participants	4 Participants	2 Participants	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline Lymphocytes	3 Participants	2 Participants	2 Participants	2 Participants	1 Participants	4 Participants	1 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline Lymphocytes (Increased)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline Lymphocytes (Decreased)	3 Participants	2 Participants	2 Participants	2 Participants	1 Participants	4 Participants	1 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline Total Neutrophils	2 Participants	0 Participants	2 Participants	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline Platelet count	3 Participants	1 Participants	5 Participants	3 Participants	1 Participants	4 Participants	0 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline WBC count	2 Participants	0 Participants	2 Participants	3 Participants	2 Participants	3 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Median of 7.286 weeks of drug exposure

Population: All Treated Population

Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration rate and heart rate. Vital signs were measured after resting for at least 5 minutes in a semi-supine position. The number of participants with critical changes in values of vital signs in response to drug have been presented.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1:Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Median of 7.286 weeks of drug exposure

Population: All Treated Population. Only those participants with data available at specific time point were analyzed.

Single measurements of 12-lead ECGs were obtained in a semi-recumbent or supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. The number of participants with abnormal - not clinically significant and abnormal - clinically significant "worst-case on-therapy" value have been presented.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=1 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters Abnormal - clinically significant	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters Abnormal - not clinically significant	4 Participants	1 Participants	4 Participants	1 Participants	1 Participants	5 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Median of 7.286 weeks of drug exposure

Population: All Treated Population

The complete physical examination included assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. A brief physical examination included assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). All abnormal physical examination findings were reported as AEs within the AE specific case report form (CRF) page. Hence, data was not captured separately for this outcome as number of participants with abnormal findings with respect to physical examinations. NA indicates data was not available as all abnormal physical examination findings were reported as AEs.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Number of Participants With Abnormal Findings Undergoing Physical Examinations	NA Participants NA indicates data was not available as all abnormal physical examination findings were reported as AEs.	NA Participants NA indicates data was not available as all abnormal physical examination findings were reported as AEs.	NA Participants NA indicates data was not available as all abnormal physical examination findings were reported as AEs.	NA Participants NA indicates data was not available as all abnormal physical examination findings were reported as AEs.	NA Participants NA indicates data was not available as all abnormal physical examination findings were reported as AEs.	NA Participants NA indicates data was not available as all abnormal physical examination findings were reported as AEs.	NA Participants NA indicates data was not available as all abnormal physical examination findings were reported as AEs.	NA Participants NA indicates data was not available as all abnormal physical examination findings were reported as AEs.	NA Participants NA indicates data was not available as all abnormal physical examination findings were reported as AEs.

PRIMARY outcome

Timeframe: Week 16

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Clinical response was planned to be assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at Week 16. Disease control rate was defined as number of participants achieving complete response (CR), partial response (PR) and stable disease (SD) per RECIST version 1.1. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15

Population: Pharmacokinetic Population

Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2879552 Day 1; n=1, 1, 5, 3, 7, 3, 2, 5, 2	32.4 Hour*Nanogram per milliliter Geometric Coefficient of Variation 15.7	60.8 Hour*Nanogram per milliliter Geometric Coefficient of Variation 13.8	86.0 Hour*Nanogram per milliliter Geometric Coefficient of Variation 57.6	190.0 Hour*Nanogram per milliliter Geometric Coefficient of Variation 29.6	148.0 Hour*Nanogram per milliliter Geometric Coefficient of Variation 29.9	155.2 Hour*Nanogram per milliliter Geometric Coefficient of Variation 29.0	129.1 Hour*Nanogram per milliliter Geometric Coefficient of Variation 26.2	10.4 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	21.6 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2879552 Day 15; n=1, 1, 5, 1, 5, 3,2, 5,0	53.6 Hour*Nanogram per milliliter Geometric Coefficient of Variation 31.5	91.1 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	144.1 Hour*Nanogram per milliliter Geometric Coefficient of Variation 64.6	122.1 Hour*Nanogram per milliliter Geometric Coefficient of Variation 30.4	164.1 Hour*Nanogram per milliliter Geometric Coefficient of Variation 7.8	184.4 Hour*Nanogram per milliliter Geometric Coefficient of Variation 40.4	—	27.0 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	40.7 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.

Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following single (Day 1) dose administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=6 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=1 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK2879552	40.0 Hour*Nanogram per milliliter Geometric Coefficient of Variation 18.7	70.7 Hour*Nanogram per milliliter Geometric Coefficient of Variation 15.0	108.6 Hour*Nanogram per milliliter Geometric Coefficient of Variation 56.1	206.3 Hour*Nanogram per milliliter Geometric Coefficient of Variation 27.7	163.6 Hour*Nanogram per milliliter Geometric Coefficient of Variation 25.3	182.9 Hour*Nanogram per milliliter Geometric Coefficient of Variation 27.1	180.9 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	14.5 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	27.2 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 15

Population: Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.

Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following repeat (Day 15) dose administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=1 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=4 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK2879552	53.3 Hour*Nanogram per milliliter Geometric Coefficient of Variation 31.2	91.1 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	143.8 Hour*Nanogram per milliliter Geometric Coefficient of Variation 64.2	141.9 Hour*Nanogram per milliliter Geometric Coefficient of Variation 32.4	164.7 Hour*Nanogram per milliliter Geometric Coefficient of Variation 8.2	203.4 Hour*Nanogram per milliliter Geometric Coefficient of Variation 37.2	—	27.3 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	40.3 Hour*Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15

Population: Pharmacokinetic Population

Blood samples were collected from participants for pharmacokinetic analysis including Cmax following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2879552 Day 15; n=1, 1, 5, 1, 5, 3, 2, 5, 0	6.9 Nanogram per milliliter Geometric Coefficient of Variation 29.2	13.8 Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	15.7 Nanogram per milliliter Geometric Coefficient of Variation 39.4	15.2 Nanogram per milliliter Geometric Coefficient of Variation 23.1	24.4 Nanogram per milliliter Geometric Coefficient of Variation 21.5	28.1 Nanogram per milliliter Geometric Coefficient of Variation 7.7	—	3.4 Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	4.3 Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2879552 Day 1; n=1, 1, 5, 3, 7, 3, 2, 5, 2	6.4 Nanogram per milliliter Geometric Coefficient of Variation 17.3	9.3 Nanogram per milliliter Geometric Coefficient of Variation 12.2	12.9 Nanogram per milliliter Geometric Coefficient of Variation 36.6	22.0 Nanogram per milliliter Geometric Coefficient of Variation 42.9	31.2 Nanogram per milliliter Geometric Coefficient of Variation 26.8	23.9 Nanogram per milliliter Geometric Coefficient of Variation 20.8	23.4 Nanogram per milliliter Geometric Coefficient of Variation 68.8	3.8 Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	2.9 Nanogram per milliliter Geometric Coefficient of Variation NA NA indicates the data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15

Population: Pharmacokinetic Population

Blood samples were collected from participants for pharmacokinetic analysis including Tmax following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Tmax is the time to reach Cmax, determined directly from the concentration-time data. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2879552 Day 15; n=1, 1, 5, 1, 5, 3, 2, 5, 0	0.9 Hours Geometric Coefficient of Variation 65.1	0.5 Hours Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	1.1 Hours Geometric Coefficient of Variation 88.6	1.5 Hours Geometric Coefficient of Variation 86.3	1.4 Hours Geometric Coefficient of Variation 52.1	1.0 Hours Geometric Coefficient of Variation 46.7	—	1.0 Hours Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	1.5 Hours Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.
Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2879552 Day 1; n=1, 1, 5, 3, 7, 3, 2, 5, 2	0.5 Hours Geometric Coefficient of Variation 2.8	1.3 Hours Geometric Coefficient of Variation 110.4	0.8 Hours Geometric Coefficient of Variation 108.5	1.6 Hours Geometric Coefficient of Variation 42.5	0.8 Hours Geometric Coefficient of Variation 85.8	1.2 Hours Geometric Coefficient of Variation 52.6	0.7 Hours Geometric Coefficient of Variation 52.1	0.5 Hours Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	1.5 Hours Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15

Population: Pharmacokinetic Population

Blood samples were collected from participants for pharmacokinetic analysis including lambda z following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. The data for Day 15 was not computed due to the long half-life of GSK2879552 . Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Apparent Terminal Phase Elimination Rate Constant (Lambda z) Following Single and Repeat Dose Administration of GSK2879552 Day 1; n= 1, 1, 5, 3, 6, 3, 2, 5, 1	0.0 Hours^-1 Geometric Coefficient of Variation 62.6	0.1 Hours^-1 Geometric Coefficient of Variation 8.7	0.0 Hours^-1 Geometric Coefficient of Variation 8.7	0.0 Hours^-1 Geometric Coefficient of Variation 19.1	0.1 Hours^-1 Geometric Coefficient of Variation 47.9	0.1 Hours^-1 Geometric Coefficient of Variation 23.2	0.1 Hours^-1 Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	0.0 Hours^-1 Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	0.0 Hours^-1 Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15

Population: Pharmacokinetic Population

Blood samples were collected from participants for pharmacokinetic analysis including T1/2 following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. The data for Day 15 was not computed due to the long half-life of GSK2879552. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of GSK2879552 Day 1; n=1, 1, 5, 3, 6, 3, 2, 5, 1	17.3 Hours Geometric Coefficient of Variation 62.6	8.8 Hours Geometric Coefficient of Variation 8.7	18.1 Hours Geometric Coefficient of Variation 8.7	15.4 Hours Geometric Coefficient of Variation 19.1	11.5 Hours Geometric Coefficient of Variation 47.9	8.9 Hours Geometric Coefficient of Variation 23.2	8.4 Hours Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	16.9 Hours Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.	24.0 Hours Geometric Coefficient of Variation NA NA indicates that data was not available since number of participants were insufficient to determine the value for Geometric coefficient of variation.

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15

Population: Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.

The accumulation ratio was analyzed using analysis of variance (ANOVA) for AUC (0-tau) on Day 15 versus AUC (0-tau) on Day 1 by dose cohort. Only dose cohorts with repeat daily dosing were analyzed. The observed accumulation ratio (Ro) was determined based on AUC data to estimate the extent of accumulation after repeat dosing. The Ro of GSK2879552 was estimated by calculating the ratio of the geometric least squares (GLS) means of the pharmacokinetic parameter between Day 15 and Day 1 for all dose levels and the corresponding 90 percent confidence interval (CI) for each ratio.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=5 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=4 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Accumulation Ratio Following Administration of GSK2879552	—	—	—	—	—	—	—	1.917 Ratio of AUC Interval 1.426 to 2.578	1.652 Ratio of AUC Interval 1.484 to 1.84

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15

Population: Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.

Time invariance was assessed to evaluate whether the pharmacokinetics remains unaltered after repeat dosing. The mixed effect model was fitted with day as a fixed effect and participant as a random effect for each treatment (dose) separately. AUC (0-tau) on Day 15 was compared to AUC (0-infinity) on Day 1 in order to assess time invariance for each dose. The ratio and 90 percent CI were calculated by back-transforming the difference between the LS means for the two days and associated 90 percent CI, for each dose. Only dose cohorts with repeat daily dosing were analyzed.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=5 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=5 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Time Invariance Ratio Following Administration of GSK2879552	0.688 Ratio of AUC Interval 0.412 to 1.149	—	—	—	—	—	—	1.332 Ratio of AUC Interval 1.112 to 1.596	1.206 Ratio of AUC Interval 1.027 to 1.417

SECONDARY outcome

Timeframe: Week 16

Population: All Treated Population.

The clinical activity of GSK2879552 given orally in participants with SCLC was evaluated by assessing disease control rate. Clinical response was assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate (CR+PR+SD) based on RECIST version 1.1 at Week 16. Disease control rate was defined as number of participants achieving CR, PR and SD per RECIST version 1.1. The number of participants achieving disease control rate have been presented.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily n=5 Participants Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily n=7 Participants Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily n=3 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 Participants Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 Participants Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=1 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 Participants Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: Number of Participants Achieving Disease Control Rate at Week 16	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and median of 7.286 weeks of drug exposure

Population: Pharmacokinetic Population

The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Estimates and standard error have been presented.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=29 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1 :Median Effective Dose (ED50) of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Dose	—	—	—	—	—	—	—	1.7444 Milligrams Standard Error 0.1436	—

SECONDARY outcome

Timeframe: Baseline and median of 7.286 weeks of drug exposure

Population: Pharmacokinetic Population

The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Estimates and standard error have been presented.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=29 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Cmax	—	—	—	—	—	—	—	10.3948 Nanogram per milliliter Standard Error 1.2666	—

SECONDARY outcome

Timeframe: Baseline and median of 7.286 weeks of drug exposure

Population: Pharmacokinetic Population

The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Estimates and standard error have been presented.

Outcome measures

Measure	Part 2:GSK2879552 1.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1:GSK2879552 0.25 mg Daily n=29 Participants Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.
Part 1: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and AUC (0 to Infinity)	—	—	—	—	—	—	—	81.8512 Hour*Nanogram per milliliter Standard Error 6.0391	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

An event was considered a DLT if it occured within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event is unrelated to treatment: recurrent Grade 3 anemia after initial transfusion or Grade 3 anemia lasting > 7 days in participants who are not transfused, Grade 4 neutropenia, Grade 3 neutropenia > 7 days duration, febrile neutropenia as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Grade 3 thrombocytopenia requiring dose reduction, Grade 4 thrombocytopenia lasting > 3 days or of any duration if associated with clinically significant bleeding, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 2 toxicity (at any time during treatment) and treatment delay of 14 days or greater due to unresolved drug-related toxicity. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

The number of participants who had any dose reduction or delay were planned to be analyzed. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Participants were planned to be monitored from start of the study till the development of toxicity in Part 2. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Blood samples were planned to be collected for evaluation of clinical chemistry parameters including potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, ALT, uric acid, glucose, GGT, albumin, sodium, calcium, alkaline phosphatase, and phosphorus inorganic. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Blood samples were planned to be collected for the analysis of hematology parameters including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Vital sign measurement includes SBP, DBP, temperature, respiration rate and heart rate. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Single measurements of 12-lead ECGs were planned to be obtained in a semi-recumbent or supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

The complete physical examination includes assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. A brief physical examination includes assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.5, and 3 hours post-dose on Day 1; Pre-dose on Day 8; Pre-dose, 0.5 to 1 hour, and 4 to 6 hours on Day 15; Pre-dose at Day 22 and up to every 4 weeks until Week 48

Population: Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.

Blood samples were planned to be collected for population pharmacokinetic analysis of GSK2879552 including clearance. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.5, and 3 hours post-dose on Day 1; Pre-dose on Day 8; Pre-dose, 0.5 to 1 hour, and 4 to 6 hours on Day 15; Pre-dose at Day 22 and up to every 4 weeks until Week 48

Population: Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.

Blood samples were planned to be collected for population pharmacokinetic analysis of GSK2879552 including volume of distribution. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Population: Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.

The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Population: Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.

The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Up to 2 years

Population: Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.

The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Duration of response for participants is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Overall response rate is defined as percentage of participants achieving CR and PR per RECIST version 1.1. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

Adverse Events

Part 1:GSK2879552 0.25 mg Daily

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1:GSK2879552 0.5 mg Daily

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1:GSK2879552 1.0 mg Daily

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1:GSK2879552 1.5 mg Daily

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: GSK2879552 2.0 mg Daily

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Part 1: GSK2879552 3.0 mg Daily

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off

Serious events: 2 serious events

Other events: 1 other events

Deaths: 1 deaths

Part 2:GSK2879552 0.25 mg Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2:GSK2879552 0.5 mg Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2:GSK2879552 1.0 mg Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2:GSK2879552 1.5 mg Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: GSK2879552 2.0 mg Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: GSK2879552 3.0 mg Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1:GSK2879552 0.25 mg Daily n=1 participants at risk Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 participants at risk Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 1.0 mg Daily n=5 participants at risk Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 1.5 mg Daily n=3 participants at risk Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 2.0 mg Daily n=7 participants at risk Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 3.0 mg Daily n=3 participants at risk Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 participants at risk Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 participants at risk Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 participants at risk Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2:GSK2879552 0.25 mg Daily Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 0.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Nervous system disorders Encephalopathy	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Asthenia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Malaise	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Cardiac disorders Myocardial infarction	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Cardiac disorders Pericardial effusion	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Other adverse events

Measure	Part 1:GSK2879552 0.25 mg Daily n=1 participants at risk Participants received GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 0.5 mg Daily n=1 participants at risk Participants received GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 1.0 mg Daily n=5 participants at risk Participants received GSK2879552 with a dose of 1.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1:GSK2879552 1.5 mg Daily n=3 participants at risk Participants received GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 2.0 mg Daily n=7 participants at risk Participants received GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 3.0 mg Daily n=3 participants at risk Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 1: GSK2879552 3.0 mg 4 Days on/3 Days Off n=2 participants at risk Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 1: GSK2879552 3.0 mg 4 Days on/10 Days Off n=5 participants at risk Participants received GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 1: GSK2879552 4.0 mg 4 Days on/10 Days Off n=2 participants at risk Participants received GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2:GSK2879552 0.25 mg Daily Participants were planned to receive GSK2879552 with a starting dose of 0.25 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 0.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 0.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 1 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2:GSK2879552 1.5 mg Daily Participants were planned to receive GSK2879552 with a dose of 1.5 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 2.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 2.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg Daily Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 28 days.	Part 2: GSK2879552 3.0 mg 4 Days on/3 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 3 days.	Part 2: GSK2879552 3.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 3.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.	Part 2: GSK2879552 4.0 mg 4 Days on/10 Days Off Participants were planned to receive GSK2879552 with a dose of 4.0 mg once daily, administered orally with approximately 200 milliliter of water for 4 days during the treatment period following buffer period of 10 days.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	42.9% 3/7 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Blood and lymphatic system disorders Thrombocytopenia	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	71.4% 5/7 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 3/3 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	40.0% 2/5 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	40.0% 2/5 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	28.6% 2/7 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	66.7% 2/3 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Constipation	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	40.0% 2/5 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	28.6% 2/7 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 2/2 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	42.9% 3/7 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	40.0% 2/5 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	40.0% 2/5 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	66.7% 2/3 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 2/2 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Nausea	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	60.0% 3/5 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	66.7% 2/3 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Asthenia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	60.0% 3/5 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Pyrexia	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	28.6% 2/7 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	40.0% 2/5 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Chest pain	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 2/2 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Chills	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Dysgeusia	100.0% 1/1 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Dysphagia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Gamma-glutamyltransferase increased	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	28.6% 2/7 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Platelet count decreased	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations White blood cell count decreased	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Metabolism and nutrition disorders Acidosis	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Amnesia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Psychiatric disorders Anxiety	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Blood bilirubin increased	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Blood creatinine increased	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Blood uric acid increased	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Infections and infestations Bronchitis	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Psychiatric disorders Confusional state	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Injury, poisoning and procedural complications Contusion	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Coordination abnormal	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Psychiatric disorders Depression	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Psychiatric disorders Disorientation	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Dizziness	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Renal and urinary disorders Dysuria	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Epilepsy	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Vascular disorders Flushing	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Gingival bleeding	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Headache	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Vascular disorders Hypertension	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Vascular disorders Hypotension	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Infections and infestations Infected bite	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Lethargy	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Lip dry	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Mucosal inflammation	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Neuropathy peripheral	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Oedema peripheral	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Orthopnoea	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Pain	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Presyncope	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	14.3% 1/7 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Rectal prolapse	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Infections and infestations Respiratory tract infection	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Restless legs syndrome	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Somnolence	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Vascular disorders Superior vena cava syndrome	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Reproductive system and breast disorders Testicular pain	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Nervous system disorders Tremor	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	100.0% 1/1 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Ear and labyrinth disorders Vertigo	100.0% 1/1 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Weight decreased	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	33.3% 1/3 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Xerosis	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/7 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/3 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/5 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/2 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-SAEs were collected in Part 1 from the start of the study treatment up to median of 7.286 weeks of drug exposure. SAEs and non-SAEs were collected in Part 1 from All Treated Population which included all participants who received at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER