Trial Outcomes & Findings for A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma (NCT NCT02082977)

NCT ID: NCT02082977

Last Updated: 2020-02-25

Results Overview

An AE is any untoward medical occurrence in a participant or 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/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on All Subjects Population which included all participants who received at least one dose of study treatment.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

Up to 3.2 years

Results posted on

2020-02-25

Participant Flow

This was a 2-part study in participants with relapsed/refractory diffuse large B cell lymphoma, transformed follicular lymphoma, other Non-Hodgkin's lymphomas, solid tumors and multiple myeloma (MM). In Part 1 dose escalation, participants received 50 to 3000 milligrams (mg) of GSK2816126, and Part 2 was dose expansion.

This study was terminated prior to the completion of Part 1 due to an unfavorable benefit risk profile. Part 2 was not conducted. Approximately 42 participants screened, of which 41 were treated in Part 1 including 20 participants with lymphoma and 21 with solid tumors, of these 22 completed, 5 died and 14 participants were withdrawn.

Participant milestones

Participant milestones
Measure	Part 1:GSK2816126 50 mg Twice-weekly Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1 (Up to 3.2 Years) STARTED	2	1	1	1	3	4	10	12	7
Part 1 (Up to 3.2 Years) COMPLETED	1	1	1	1	2	1	4	7	4
Part 1 (Up to 3.2 Years) NOT COMPLETED	1	0	0	0	1	3	6	5	3
Part 2 (Up to 3.2 Years) STARTED	0	0	0	0	0	0	0	0	0
Part 2 (Up to 3.2 Years) COMPLETED	0	0	0	0	0	0	0	0	0
Part 2 (Up to 3.2 Years) NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1:GSK2816126 50 mg Twice-weekly Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1 (Up to 3.2 Years) Death	1	0	1	2	0	1
Part 1 (Up to 3.2 Years) Study closed/terminated	0	0	0	0	2	0
Part 1 (Up to 3.2 Years) Lost to Follow-up	0	0	1	0	0	0
Part 1 (Up to 3.2 Years) Physician Decision	0	1	1	4	1	2
Part 1 (Up to 3.2 Years) Withdrawal by Subject	0	0	0	0	2	0

Baseline Characteristics

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 2: All Participants Participants with Germinal Center B-cell-like Diffuse Large B-cell Lymphoma (GCB-DLBCL)-mutant and wild type, Transformed Follicular Lymphoma (TFL)-mutant and wild type as well as with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive recommended Phase II dose (RP2D) .	Total n=41 Participants Total of all reporting groups
Age, Continuous	44.0 Years STANDARD_DEVIATION 12.73 • n=5 Participants	54.0 Years STANDARD_DEVIATION NA • n=7 Participants	56.0 Years STANDARD_DEVIATION NA • n=5 Participants	69.0 Years STANDARD_DEVIATION NA • n=4 Participants	53.3 Years STANDARD_DEVIATION 4.04 • n=21 Participants	49.5 Years STANDARD_DEVIATION 17.18 • n=10 Participants	61.1 Years STANDARD_DEVIATION 14.10 • n=115 Participants	61.9 Years STANDARD_DEVIATION 14.65 • n=24 Participants	58.4 Years STANDARD_DEVIATION 14.30 • n=42 Participants	—	58.2 Years STANDARD_DEVIATION 13.81 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	7 Participants n=24 Participants	4 Participants n=42 Participants	—	16 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	8 Participants n=115 Participants	5 Participants n=24 Participants	3 Participants n=42 Participants	—	25 Participants n=42 Participants
Race/Ethnicity, Customized African American/African Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	—	1 Participants n=42 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	—	1 Participants n=42 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	8 Participants n=115 Participants	12 Participants n=24 Participants	5 Participants n=42 Participants	—	37 Participants n=42 Participants
Race/Ethnicity, Customized Mixed white race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	—	1 Participants n=42 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	—	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 3.2 years

Population: All Subjects Population

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) Any Non-SAE	2 Participants	1 Participants	1 Participants	1 Participants	3 Participants	4 Participants	10 Participants	12 Participants	7 Participants
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) Any SAE	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	5 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Population: All Subjects Population

An event was considered a DLT if it occurred within first 4 weeks (28 days) of treatment, and met the criteria's for hematologic , non-hematologic, infusion reactions and other toxicities, unless it can be clearly established that the event is unrelated to treatment.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Number of Participants With Dose Limiting Toxicities (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to 3.2 years

Population: All Subjects Population

A participant was considered to have completed the study if they have completed their end of study visit or if the participant died or was still in follow-up at the time the study was closed or terminated. Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to AEs have been presented.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Number of Participants Withdrawn Due to AEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 3.2 years

Population: All Subjects Population

The number of participants who had any dose interruptions have been presented.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Number of Participants With Dose Interruptions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	5 Participants

PRIMARY outcome

Timeframe: Up to 3.2 years

Population: All Subjects Population

The number of participants who had any dose reductions have been presented.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Number of Participants With Dose Reductions	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline and up to 3.2 years

Population: All Subjects Population

Blood samples were collected for evaluation of clinical chemistry parameters including direct bilirubin, chloride, lactate dehydrogenase (LDH), total protein, urea/blood urea nitrogen (BUN) and uric acid. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are not gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin; To Low; n=1,1,1,1,3,4,8,12,7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin; To Normal; n=1,1,1,1,3,4,8,12,7	1 Participants	1 Participants	1 Participants	0 Participants	3 Participants	4 Participants	8 Participants	9 Participants	7 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin; To High; n=1,1,1,1,3,4,8,12,7	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Chloride; To Low;n=2,1,1,1,3,4,10,12,7	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	3 Participants	1 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Chloride; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters LDH; To Low; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters LDH; To High; n=2,1,1,1,3,4,10,12,7	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	2 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Total Protein; To Low n=2,1,1,1,3,4,10,12,7	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	3 Participants	3 Participants	2 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Total Protein; To Normal; n=2,1,1,1,3,4,10,12,7	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	4 Participants	8 Participants	9 Participants	5 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Total Protein; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Urea/BUN; To Low; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Urea/BUN; To Normal; n=2,1,1,1,3,4,10,12,7	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	4 Participants	7 Participants	5 Participants	4 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Uric acid; To Low; n=2,1,1,1,3,4,10,12,7	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Uric acid; To Normal; n=2,1,1,1,3,4,10,12,7	2 Participants	0 Participants	0 Participants	0 Participants	3 Participants	3 Participants	7 Participants	8 Participants	4 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Uric acid; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	4 Participants	2 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Chloride; To Normal; n=2,1,1,1,3,4,10,12,7	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	4 Participants	6 Participants	8 Participants	6 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters LDH; To Normal; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	4 Participants	8 Participants	9 Participants	5 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters Urea/BUN; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	3 Participants	6 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline and up to 3.2 years

Population: All Subjects Population

Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, segmented (seg) neutrophils, red blood cell (RBC) count and reticulocytes. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are not gradable by CTCAE version 4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters RBC count; To Normal; n=2,1,1,1,3,4,10,12,7	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	4 Participants	6 Participants	8 Participants	4 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters RBC count; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Reticulocytes; ; To Low; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	5 Participants	2 Participants	3 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Basophils; To Low; n=2,1,1,1,3,4,10,12,7	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	3 Participants	2 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Basophils; To Normal; n=2,1,1,1,3,4,10,12,7	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	3 Participants	9 Participants	9 Participants	5 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Eosinophils; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Hematocrit; To Low; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants	4 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters MCV; To Low; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Monocytes; To Low; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Monocytes; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	5 Participants	2 Participants	1 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Reticulocytes; To Normal; n=2,1,1,1,3,4,10,12,7	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	3 Participants	5 Participants	10 Participants	4 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Reticulocytes; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Basophils; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Eosinophils; To Low; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Eosinophils; To Normal; n=2,1,1,1,3,4,10,12,7	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	3 Participants	7 Participants	10 Participants	7 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Hematocrit; To Normal; n=2,1,1,1,3,4,10,12,7	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants	4 Participants	8 Participants	10 Participants	3 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Hematocrit; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters MCHC; To Low; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	7 Participants	5 Participants	2 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters MCHC; To Normal; n=2,1,1,1,3,4,10,12,7	2 Participants	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants	2 Participants	7 Participants	5 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters MCHC; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters MCH; To Low; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters MCH; To Normal; n=2,1,1,1,3,4,10,12,7	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	4 Participants	7 Participants	11 Participants	7 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters MCH; To High; n=2,1,1,1,3,4,10,12,7	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters MCV; To Normal; n=2,1,1,1,3,4,10,12,7	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	3 Participants	9 Participants	11 Participants	7 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters MCV; To High; n=2,1,1,1,3,4,10,12,7	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Monocytes; To Normal; n=2,1,1,1,3,4,10,12,7	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants	4 Participants	5 Participants	9 Participants	5 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters RBC count; To Low; n=2,1,1,1,3,4,10,12,7	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants	4 Participants	3 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Seg Neutrophils; To Low; n= 0,0,0,0,0,0,0,0,1	—	—	—	—	—	—	—	—	0 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Seg Neutrophils; To Normal; n= 0,0,0,0,0,0,0,0,1	—	—	—	—	—	—	—	—	1 Participants
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters Seg Neutrophils; To High; n= n= 0,0,0,0,0,0,0,0,1	—	—	—	—	—	—	—	—	0 Participants

PRIMARY outcome

Timeframe: Up to 3.2 years

Population: All Subjects Population

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

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:Number of Participants With Abnormal Values for Vital Signs SBP	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	3 Participants	0 Participants
Part 1:Number of Participants With Abnormal Values for Vital Signs DBP	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	5 Participants	0 Participants
Part 1:Number of Participants With Abnormal Values for Vital Signs Heart rate	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants
Part 1:Number of Participants With Abnormal Values for Vital Signs Body temperature	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 3.2 years

Population: All Subjects Population

Single measurements of 12-lead ECGs were obtained a semi-recumbent or semi-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, abnormal-not clinically significant (NCS), and abnormal-clinically significant (CS) worst case Post Baseline findings have been presented.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters Abnormal; NCS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	6 Participants	2 Participants
Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters Abnormal; CS	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters Abnormal	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	5 Participants	5 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to 3.2 years

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

Overall response rate is defined as percentage of participants achieving complete response and partial response per Response Evaluation Criteria in Solid Tumors (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, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)

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 GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. The analysis was performed on Pharmacokinetic Population which included all participants in the All Subject population for whom a blood sample for pharmacokinetics was analyzed and at least 1 non-missing values was obtained. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
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 GSK2816126 Day 1; n=2,1,1,1,3,4,10,12,7	1.20 Hour*microgram per milliliter Geometric Coefficient of Variation 62	27.20 Hour*microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	27.70 Hour*microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	11.80 Hour*microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	24.18 Hour*microgram per milliliter Geometric Coefficient of Variation 10	85.72 Hour*microgram per milliliter Geometric Coefficient of Variation 91	45.93 Hour*microgram per milliliter Geometric Coefficient of Variation 23	92.41 Hour*microgram per milliliter Geometric Coefficient of Variation 26	93.96 Hour*microgram per milliliter Geometric Coefficient of Variation 48
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 GSK2816126 Day 15; n=1,1,1,1,3,4,9,11,4	3.20 Hour*microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	5.70 Hour*microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	7.10 Hour*microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	13.10 Hour*microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	25.82 Hour*microgram per milliliter Geometric Coefficient of Variation 30	53.41 Hour*microgram per milliliter Geometric Coefficient of Variation 14	68.72 Hour*microgram per milliliter Geometric Coefficient of Variation 75	105.29 Hour*microgram per milliliter Geometric Coefficient of Variation 29	158.44 Hour*microgram per milliliter Geometric Coefficient of Variation 35

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 12, 18 , 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 (Each cycle was of 28 days)

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 GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Pharmacokinetic parameter derivation for some participants did not strictly conform to the prescribed acceptance criteria and hence data was not available for those participants.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
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 GSK2816126	1.33 Hour*Microgram per milliliter Geometric Coefficient of Variation 82	—	—	13.20 Hour*Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	26.41 Hour*Microgram per milliliter Geometric Coefficient of Variation 12	60.90 Hour*Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	51.15 Hour*Microgram per milliliter Geometric Coefficient of Variation 23	102.48 Hour*Microgram per milliliter Geometric Coefficient of Variation 28	103.17 Hour*Microgram per milliliter Geometric Coefficient of Variation 48

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 15 (Each cycle was of 28 days)

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 GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=9 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=11 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK2816126	2.90 Hour*Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	5.70 Hour*Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	7.10 Hour*Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	12.30 Hour*Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	26.85 Hour*Microgram per milliliter Geometric Coefficient of Variation 25	53.66 Hour*Microgram per milliliter Geometric Coefficient of Variation 14	59.70 Hour*Microgram per milliliter Geometric Coefficient of Variation 25	111.32 Hour*Microgram per milliliter Geometric Coefficient of Variation 25	157.88 Hour*Microgram per milliliter Geometric Coefficient of Variation 36

SECONDARY outcome

Timeframe: Pre-dose from start of infusion till end of infusion on Cycle 1 of Day 8; Pre-dose, 0.5, 1, 2, 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 15 (Each cycle was of 28 days)

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

Blood samples were collected from participants for pharmacokinetic analysis including Ctau following specified days (Days 8 and 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available as data could not be calculated due to limited number of participants at specified data point. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Trough (Pre-dose) Concentration at the End of Dosing Interval on the Specified Days (Ctau) Following Administration of GSK2816126 Day 8; n=2,1,1,1,3,4,9,11,6	NA Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available due to limited number of participants to calculate the data.	NA Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available due to limited number of participants to calculate the data.	NA Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available due to limited number of participants to calculate the data.	NA Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available due to limited number of participants to calculate the data.	0.10 Microgram per milliliter Geometric Coefficient of Variation 0	0.14 Microgram per milliliter Geometric Coefficient of Variation 79	0.15 Microgram per milliliter Geometric Coefficient of Variation 38	0.33 Microgram per milliliter Geometric Coefficient of Variation 97	0.41 Microgram per milliliter Geometric Coefficient of Variation 147
Part 1: Trough (Pre-dose) Concentration at the End of Dosing Interval on the Specified Days (Ctau) Following Administration of GSK2816126 Day 15; n=1,1,1,1,3,4,10,11,4	NA Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available due to limited number of participants to calculate the data.	NA Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available due to limited number of participants to calculate the data.	NA Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available due to limited number of participants to calculate the data.	NA Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available due to limited number of participants to calculate the data.	0.10 Microgram per milliliter Geometric Coefficient of Variation 0	0.13 Microgram per milliliter Geometric Coefficient of Variation 59	0.16 Microgram per milliliter Geometric Coefficient of Variation 43	0.26 Microgram per milliliter Geometric Coefficient of Variation 56	0.54 Microgram per milliliter Geometric Coefficient of Variation 169

SECONDARY outcome

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 GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2816126 Day 1; n=2,1,1,1,3,4,10,12,7	0.42 Microgram per milliliter Geometric Coefficient of Variation 52	1.10 Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	1.40 Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	4.00 Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	7.31 Microgram per milliliter Geometric Coefficient of Variation 16	10.91 Microgram per milliliter Geometric Coefficient of Variation 10	13.04 Microgram per milliliter Geometric Coefficient of Variation 27	22.26 Microgram per milliliter Geometric Coefficient of Variation 35	23.83 Microgram per milliliter Geometric Coefficient of Variation 21
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2816126 Day 15; n=1,1,1,1,3,4,9,11,4	0.50 Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	1.00 Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	1.50 Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	3.50 Microgram per milliliter Geometric Coefficient of Variation NA NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.	7.46 Microgram per milliliter Geometric Coefficient of Variation 13	11.62 Microgram per milliliter Geometric Coefficient of Variation 27	14.21 Microgram per milliliter Geometric Coefficient of Variation 27	21.62 Microgram per milliliter Geometric Coefficient of Variation 27	30.48 Microgram per milliliter Geometric Coefficient of Variation 14

SECONDARY outcome

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 GSK2816126. Tmax is the time to reach Cmax, determined directly from the concentration-time data. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2816126 Day 1; n=2,1,1,1,3,4,10,12,7	1.50 Hours Interval 1.0 to 2.0	1.00 Hours Interval 1.0 to 1.0	2.00 Hours Interval 2.0 to 2.0	1.90 Hours Interval 1.9 to 1.9	1.00 Hours Interval 0.5 to 1.9	2.05 Hours Interval 1.1 to 72.0	1.95 Hours Interval 1.0 to 2.9	2.00 Hours Interval 0.8 to 2.8	2.00 Hours Interval 0.5 to 3.3
Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2816126 Day 15; n=1,1,1,1,3,4,9,11,4	2.70 Hours Interval 2.7 to 2.7	2.00 Hours Interval 2.0 to 2.0	1.00 Hours Interval 1.0 to 1.0	1.00 Hours Interval 1.0 to 1.0	2.00 Hours Interval 1.9 to 2.0	2.05 Hours Interval 2.0 to 2.1	1.90 Hours Interval 0.5 to 2.7	2.00 Hours Interval 1.0 to 3.0	2.25 Hours Interval 2.0 to 3.0

SECONDARY outcome

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 GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. Pharmacokinetic parameter derivation for some participants did not strictly conform to the prescribed acceptance criteria and hence data was not available for those participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Apparent Terminal Phase Elimination Rate Constant (Lambda z) Following Single and Repeat Dose Administration of GSK2816126 Day 1; n=2,0,0,1,3,1,10,10,7	0.15 Hours^-1 Interval 0.1 to 0.2	—	—	0.00 Hours^-1 Interval 0.0 to 0.0	0.00 Hours^-1 Interval 0.0 to 0.0	0.00 Hours^-1 Interval 0.0 to 0.0	0.00 Hours^-1 Interval 0.0 to 0.0	0.00 Hours^-1 Interval 0.0 to 0.0	0.00 Hours^-1 Interval 0.0 to 0.1
Part 1: Apparent Terminal Phase Elimination Rate Constant (Lambda z) Following Single and Repeat Dose Administration of GSK2816126 Day 15; n=1,1,0,1,2,4,9,11,4	0.00 Hours^-1 Interval 0.0 to 0.0	0.00 Hours^-1 Interval 0.0 to 0.0	—	0.00 Hours^-1 Interval 0.0 to 0.0	0.00 Hours^-1 Interval 0.0 to 0.0	0.00 Hours^-1 Interval 0.0 to 0.0	0.00 Hours^-1 Interval 0.0 to 0.1	0.00 Hours^-1 Interval 0.0 to 0.1	0.00 Hours^-1 Interval 0.0 to 0.0

SECONDARY outcome

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 GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. Pharmacokinetic parameter derivation for some participants did not strictly conform to the prescribed acceptance criteria and hence data was not available for those participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of GSK2816126 Day 1; n=2,0,0,1,3,1,10,10,7	8.90 Hours Interval 4.3 to 13.5	—	—	49.10 Hours Interval 49.1 to 49.1	27.20 Hours Interval 19.4 to 35.2	14.10 Hours Interval 14.1 to 14.1	32.55 Hours Interval 23.0 to 39.0	32.10 Hours Interval 25.6 to 48.8	21.80 Hours Interval 8.5 to 45.3
Part 1: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of GSK2816126 Day 15; n=1,1,0,1,2,4,9,11,4	46.50 Hours Interval 46.5 to 46.5	36.80 Hours Interval 36.8 to 36.8	—	39.70 Hours Interval 39.7 to 39.7	27.40 Hours Interval 25.7 to 29.1	26.85 Hours Interval 23.0 to 33.8	30.00 Hours Interval 12.2 to 65.7	25.70 Hours Interval 8.2 to 38.3	30.20 Hours Interval 15.1 to 40.3

SECONDARY outcome

Population: Pharmacokinetic Population. To assess accumulation ratio by ANOVA, it requires at least 2 participants to derive PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15 which was not observed for dose 50mg, 100mg, 200mg and 400mg. Hence data could not be calculated for these 4 arms.

Accumulation ratio was determined from the ratio of AUC (0-tau) on Cycle 1 Day 15/AUC (0-tau) on Cycle 1 Day 1 by dose cohort. Only those participants with data available at the specified data points were analyzed. To assess accumulation ratio for a dose level based on ANOVA method, it was required that at least 2 participants had derived PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15. For dose 100mg, 200mg and 400mg, only 1 participant received treatment. For dose 50mg, 2 participants received treatment but there was one participant whose AUC(0- tau) on Cycle 1 Day 15 could not be derived due to discontinuation of treatment before Day 15. Hence, accumulation ratio could not be calculated for these 4 arms. Accumulation ratio of GSK2816126 was estimated by calculating the ratio of geometric least squares (GLS) means of the AUC between Day 15 and Day 1 for all dose levels and corresponding 90 percent (%) confidence interval (CI) for each ratio.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=9 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=11 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Accumulation Ratio Following Administration of GSK2816126	1.090 Ratio of AUC Interval 0.827 to 1.435	0.625 Ratio of AUC Interval 0.291 to 1.345	1.288 Ratio of AUC Interval 1.173 to 1.415	1.224 Ratio of AUC Interval 1.081 to 1.386	1.801 Ratio of AUC Interval 0.819 to 3.959	—	—	—	—

SECONDARY outcome

Population: Pharmacokinetic Population. To assess time invariance by ANOVA, it requires at least 2 participants to have AUC(0-inf) and AUC(0-tau) on Cycle1 Day15 which was not observed for dose 50mg, 100mg, 200mg, 400mg. For 1200mg, AUC(0-inf) on Cycle1 Day1 for 3 participants did not meet acceptance criteria. Data could not be calculated for these 5 arms.

Ratio of AUC(0-tau) on Day15/Day1 AUC(0-inf) was calculated to assess time invariance. Only those participants with data available at specified data points were analyzed. To assess time invariance based on ANOVA method, it is required that at least 2 participants in a dose level had AUC(0-inf) on Cycle1 Day1 and AUC(0-tau) on Cycle1 Day15. For dose 100mg, 200mg and 400mg, only 1 participant received treatment. For 50mg, 2 participants received treatment but there was one participant whose AUC(0-tau) on Cycle1 Day15 could not be derived due to discontinuation of treatment before Day15, so time invariance could not be calculated. For 1200mg, 4 participants received treatment, however, AUC(0-inf) derivation on Cycle1 Day1 for 3 out of 4 participants did not strictly conform to the prescribed acceptance criteria. Time invariance ratio of GSK2816126 was estimated by calculating ratio of GLS means of AUC between Day15 and Day1 for all dose levels and corresponding 90% CI for each ratio.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=9 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=9 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Time Invariance Ratio Following Administration of GSK2816126	1.016 Ratio of AUC Interval 0.814 to 1.269	1.157 Ratio of AUC Interval 1.074 to 1.247	1.091 Ratio of AUC Interval 0.937 to 1.269	1.606 Ratio of AUC Interval 0.806 to 3.198	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 3.2 years

Population: Pharmacodynamic Population. Analysis was not performed as pharmacodynamic response was not observed.

The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was planned to be characterized by linear and/or non-linear mixed effect models. This analysis was planned to be based on Pharmacodynamic Population which consists of participants in the All Subjects population for whom a pharmacodynamics/biomarkers sample was obtained and analyzed. This analysis was planned but not performed as the pharmacodynamic response was not observed and therefore a relationship between pharmacokinetic and pharmacodynamic parameters could not be determined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3.2 years

Population: Pharmacodynamic Population. Analysis was not performed as pharmacodynamic response was not observed.

The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was characterized by linear and/or non-linear mixed effect models. This analysis was planned but not performed as the pharmacodynamic response was not observed and therefore a relationship between pharmacokinetic and pharmacodynamic parameters could not be determined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 3.2 years

Population: Pharmacodynamic Population

The pre and post-treatment samples for tumor or surrogate tissue/body fluid (e.g. Peripheral blood mononuclear cell \[PBMCs\], blood, skin or hair) were collected for the analysis of H3K27me3. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was defined as any visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Number of Participants With Overall Change in Tri-methylated Histone H3 Lysine 27 (H3K27me3) Ratios Compared to Baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 3.2 years

Population: All Subjects Population.Only those participants with data available at specific time point were analyzed. No participants with solid tumors were treated at doses below 800mg (i.e. 50mg, 100mg, 200mg, 400mg). Hence data could not be calculated for these 4 arms.

Overall response rate is defined as percentage of participants achieving complete response and partial response per RECIST version 1.1. Complete Response is the disappearance of all target/non-target lesions. Partial Response is at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The percentage of participants with solid tumors (including prostate) achieving best overall response rate have been presented. No participants with solid tumors were treated at doses below 800mg (i.e. 50mg, 100mg, 200mg, 400mg). Hence data could not be calculated for these 4 arms.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=5 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=8 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=5 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Percentage of Participants With Solid Tumors Achieving Best Overall Response Rate	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 3.2 years

Population: All Subjects Population

Overall response rate is defined as percentage of participants achieving complete response and partial response per RECIST version 1.1. Complete Response is the disappearance of all target/non-target lesions. Partial Response is at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The percentage of participants with lymphoma achieving best overall response rate have been presented.

Outcome measures

Outcome measures
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 Participants Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=5 Participants Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=4 Participants Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=2 Participants Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1: Percentage of Participants With Lymphoma Achieving Best Overall Response Rate	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	20 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Population: Pharmacokinetic Population. Samples were not collected due to early study termination.

Blood samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 15

Population: Pharmacokinetic Population. Samples were not collected due to early study termination.

Bile samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites via the Entero-Test. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15

Population: Pharmacokinetic Population. Samples were not collected due to early study termination.

Urine samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15

Population: Pharmacokinetic Population Samples were not collected due to early study termination.

The amount of GSK2816126 excreted in urine after dosing at steady state was determined. The concentration of GSK2816126 in urine was planned to be measured with an investigational bio-analytical method and extrapolated to total amount excreted in urine over time using urine volume. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3.2 years

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

An AE is any untoward medical occurrence in a participant or 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/ incapacity, 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 4 weeks

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3.2 years

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

A participant was considered to have completed the study if they have completed their end of study visit or if the participant died or was still in follow-up at the time the study was closed or terminated. 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 3.2 years

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

The number of participants who had any dose interruptions were planned to be analyzed. However, this analysis was 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 3.2 years

Population: All Subjects Population. Data was 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: Baseline and up to 3.2 years

Population: All Subjects Population. Data was 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 direct bilirubin, chloride, LDH, total protein, urea/BUN and uric acid. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to 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 3.2 years

Population: All Subjects Population. Data was 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 basophils, eosinophils, hematocrit, MCHC, MCH, MCV, monocytes, seg neutrophils, RBC count and reticulocytes. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to 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 3.2 years

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

Vital sign measurements includes SBP, DBP, body temperature 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 3.2 years

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

Single measurements of 12-lead ECGs were planned to be obtained a semi-recumbent or semi-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 3.2 years

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

Blood samples were planned to be collected at Pre-dose, single draw between 0.5 and 1.9 hours from start of infusion, single draw between 3-6 hours following end of infusion on Day 1 and Day 11; Pre-dose on Day 4; Day 8, Day 11; Pre-dose on Day 15 for Cycle 1 and Cycles 2, 4, 6 and 12 pre-dose and within 5 minutes prior to end of infusion on Day 4 for population pharmacokinetic analysis of GSK2816126 including clearance. Each cycle was of 28 days. 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 3.2 years

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

Blood samples were planned to be collected on Pre-dose, single draw between 0.5 and 1.9 hours from start of infusion, single draw between 3-6 hours following end of infusion on Day 1 and Day 11; Pre-dose on Day 4; Day 8,Day 11; Pre-dose on Day 15 for Cycle 1 and Cycle 2, 4, 6 and 12 pre-dose and within 5 minutes prior to end of infusion on Day 4 for population pharmacokinetic analysis of GSK2816126 including clearance. Each cycle was of 28 days. 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 3.2 years

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3.2 years

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 3.2 years

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

The pre and post-treatment samples for tumor or surrogate tissue/body fluid (e.g. PBMCs, blood, skin or hair) were planned to be collected for the analysis of H3K27me3. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. 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: Pre-dose, single draw between 0.5 and 1.9 hours from start of infusion, single draw between 3-6 hours following end of infusion on Day 1; Pre-dose on Day 15 for Cycle 1 and Cycles 2, 4, 6 and 12 (Each cycle was of 28 days)

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

Blood samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. 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: Day 15

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

Bile samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites via the Entero-Test. 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 and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15

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

Urine samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. 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 and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15

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

The amount of GSK2816126 excreted in urine after dosing at steady state was planned to be determined. The concentration of GSK2816126 in urine was planned to be measured with an investigational bio-analytical method and extrapolated to total amount excreted in urine over time using urine volume. 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 21 days

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

Plasma analysis for 4-beta-hydroxycholesterol and cholesterol was planned to be conducted. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to 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 3.2 years

Population: All Subjects Population. Data was 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 3.2 years

Population: All Subjects Population. Data was 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

Adverse Events

Part 1:GSK2816126 50 mg Twice-weekly

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Part 1:GSK2816126 100 mg Twice-weekly

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1:GSK2816126 200 mg Twice-weekly

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1:GSK2816126 400 mg Twice-weekly

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1:GSK2816126 800 mg Twice-weekly

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1:GSK2816126 1200 mg Twice-weekly

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Part 1:GSK2816126 1800 mg Twice-weekly

Serious events: 1 serious events

Other events: 10 other events

Deaths: 2 deaths

Part 1:GSK2816126 2400 mg Twice-weekly

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 1:GSK2816126 3000 mg Twice-weekly

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Part 2: All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 participants at risk Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 participants at risk Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 participants at risk Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 participants at risk Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 participants at risk Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 participants at risk Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 participants at risk Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 participants at risk Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 participants at risk Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 2: All Participants Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
General disorders Pyrexia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Back pain	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Campylobacter infection	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Enterocolitis	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Pneumonia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Skin bacterial infection	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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

Other adverse events
Measure	Part 1:GSK2816126 50 mg Twice-weekly n=2 participants at risk Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 100 mg Twice-weekly n=1 participants at risk Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 200 mg Twice-weekly n=1 participants at risk Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 400 mg Twice-weekly n=1 participants at risk Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 800 mg Twice-weekly n=3 participants at risk Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1200 mg Twice-weekly n=4 participants at risk Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 1800 mg Twice-weekly n=10 participants at risk Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 2400 mg Twice-weekly n=12 participants at risk Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 1:GSK2816126 3000 mg Twice-weekly n=7 participants at risk Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).	Part 2: All Participants Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 2/4 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	60.0% 6/10 • Number of events 6 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	58.3% 7/12 • Number of events 7 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 3 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 2/4 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	30.0% 3/10 • Number of events 6 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	75.0% 9/12 • Number of events 10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 6 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	30.0% 3/10 • Number of events 5 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 6/12 • Number of events 6 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 5 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	30.0% 3/10 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 6/12 • Number of events 6 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 3 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 2/4 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 2/10 • Number of events 4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	16.7% 2/12 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	60.0% 6/10 • Number of events 6 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 3/12 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 2/10 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Infusion related reaction	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	16.7% 2/12 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 11 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	16.7% 2/12 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	16.7% 2/12 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	50.0% 2/4 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 3 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	16.7% 2/12 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	16.7% 2/12 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	16.7% 2/12 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	16.7% 2/12 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Psychiatric disorders Hallucination, auditory	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Back pain	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 3/12 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	16.7% 2/12 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Psychiatric disorders Insomnia	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 2/10 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 2/10 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Urinary tract infection	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 discomfort	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	20.0% 2/10 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 discomfort	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	16.7% 2/12 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 3 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Electrocardiogram QT prolonged	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Vascular disorders Hot flush	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Hypoaesthesia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Influenza like illness	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Lower respiratory tract infection	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Medical device site reaction	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Night sweats	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Cardiac disorders Tachycardia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Upper respiratory tract infection	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Urticaria	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 tenderness	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Anal paraesthesia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Application site pruritus	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 decreased	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 decreased	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Complication associated with device	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Eye disorders Conjunctival hyperaemia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Vascular disorders Deep vein thrombosis	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Dehydration	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Immune system disorders Drug hypersensitivity	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Dysaesthesia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Ear disorder	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Electrocardiogram T wave abnormal	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Face oedema	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Febrile neutropenia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Feeling abnormal	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Feeling hot	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Feeling of body temperature change	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Furuncle	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Gastroenteritis	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Hydronephrosis	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Hypercalcaemia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Hyperhidrosis	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Lymphocyte count decreased	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Vascular disorders Lymphoedema	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Muscle contractions involuntary	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Muscle twitching	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Nasopharyngitis	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Neuralgia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Neutrophil count decreased	50.0% 1/2 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Non-cardiac chest pain	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Oral candidiasis	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Oropharyngeal pain	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Palmar erythema	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Pneumonitis	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Pollakiuria	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Procedural pain	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Pulmonary embolism	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 macular	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 papular	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 tenesmus	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Rhinitis	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Rhinorrhoea	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	10.0% 1/10 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Sinus congestion	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Skin abrasion	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Skin infection	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Skin necrosis	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
General disorders Suprapubic pain	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Telangiectasia	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Tooth abscess	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Urine output decreased	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Viral infection	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Eye disorders Vision blurred	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
Investigations Vitamin D decreased	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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	50.0% 1/2 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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 Wound infection	0.00% 0/2 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/10 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at 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-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.	— 0/0 • Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years. SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive 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: [email protected]

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