Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113) (NCT NCT01449461)

Last Updated: 2021-08-17

Results Overview

The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

137 participants

Primary outcome timeframe

28 days

Results posted on

2021-08-17

Participant Flow

Participants took part in the study at 9 investigative sites in the United States and Spain from 20 September 2011 to 18 February 2020.

Participants with advanced malignancies, all histologies other than leukemia were enrolled in dose-escalation and participants with non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangements were enrolled in dose expansion phase. Participants received brigatinib 30 mg - 300 mg, tablets, orally once daily or twice daily.

Participant milestones

Participant milestones
Measure	Brigatinib 90 mg QD-180 mg QD Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 30 mg QD/60 mg QD Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Overall Study STARTED	32	48	15	6	18	18
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	32	48	15	6	18	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Brigatinib 90 mg QD-180 mg QD Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 30 mg QD/60 mg QD Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Overall Study Adverse Event	3	4	4	0	3	2
Overall Study Death	0	7	1	0	2	0
Overall Study Physician Decision	4	1	0	0	1	0
Overall Study Documented Progressive Disease	15	24	5	4	7	14
Overall Study Clinical Progressive Disease	3	4	2	2	2	0
Overall Study Protocol Violation	1	0	0	0	0	0
Overall Study Site Terminated by Sponsor	3	4	1	0	1	2
Overall Study Withdrawal by Subject	0	2	1	0	1	0
Overall Study Reason not Specified	3	2	1	0	1	0

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brigatinib 30 mg QD/60 mg QD n=6 Participants Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=18 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=18 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=32 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=48 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=15 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Total n=137 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 9.30 • n=93 Participants	57.9 years STANDARD_DEVIATION 12.93 • n=4 Participants	57.8 years STANDARD_DEVIATION 10.91 • n=27 Participants	55.7 years STANDARD_DEVIATION 11.41 • n=483 Participants	53.9 years STANDARD_DEVIATION 11.10 • n=36 Participants	58.5 years STANDARD_DEVIATION 15.60 • n=10 Participants	56.4 years STANDARD_DEVIATION 12.02 • n=115 Participants
Age, Customized Adults [18-64 years]	2 Participants n=93 Participants	11 Participants n=4 Participants	12 Participants n=27 Participants	25 Participants n=483 Participants	39 Participants n=36 Participants	9 Participants n=10 Participants	98 Participants n=115 Participants
Age, Customized From 65 to 84 years	4 Participants n=93 Participants	7 Participants n=4 Participants	6 Participants n=27 Participants	7 Participants n=483 Participants	9 Participants n=36 Participants	6 Participants n=10 Participants	39 Participants n=115 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	12 Participants n=4 Participants	13 Participants n=27 Participants	14 Participants n=483 Participants	29 Participants n=36 Participants	8 Participants n=10 Participants	79 Participants n=115 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	6 Participants n=4 Participants	5 Participants n=27 Participants	18 Participants n=483 Participants	19 Participants n=36 Participants	7 Participants n=10 Participants	58 Participants n=115 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	4 Participants n=4 Participants	3 Participants n=27 Participants	3 Participants n=483 Participants	5 Participants n=36 Participants	2 Participants n=10 Participants	17 Participants n=115 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized White	6 Participants n=93 Participants	13 Participants n=4 Participants	13 Participants n=27 Participants	27 Participants n=483 Participants	39 Participants n=36 Participants	12 Participants n=10 Participants	110 Participants n=115 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	5 Participants n=93 Participants	18 Participants n=4 Participants	18 Participants n=27 Participants	31 Participants n=483 Participants	47 Participants n=36 Participants	15 Participants n=10 Participants	134 Participants n=115 Participants
Region of Enrollment United States	6 Participants n=93 Participants	18 Participants n=4 Participants	18 Participants n=27 Participants	32 Participants n=483 Participants	41 Participants n=36 Participants	15 Participants n=10 Participants	130 Participants n=115 Participants
Region of Enrollment Spain	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	7 Participants n=36 Participants	0 Participants n=10 Participants	7 Participants n=115 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Score 0	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	13 Participants n=483 Participants	13 Participants n=36 Participants	2 Participants n=10 Participants	34 Participants n=115 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Score 1	6 Participants n=93 Participants	15 Participants n=4 Participants	15 Participants n=27 Participants	19 Participants n=483 Participants	33 Participants n=36 Participants	13 Participants n=10 Participants	101 Participants n=115 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Score 2	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Time Since Diagnosis of Cancer	2.48 years STANDARD_DEVIATION 3.303 • n=93 Participants	3.33 years STANDARD_DEVIATION 2.184 • n=4 Participants	2.41 years STANDARD_DEVIATION 1.346 • n=27 Participants	3.19 years STANDARD_DEVIATION 2.726 • n=483 Participants	2.77 years STANDARD_DEVIATION 2.053 • n=36 Participants	3.27 years STANDARD_DEVIATION 1.913 • n=10 Participants	2.93 years STANDARD_DEVIATION 2.192 • n=115 Participants
Participants with Diagnosis of Cancer Type NSCLC	3 Participants n=93 Participants	16 Participants n=4 Participants	18 Participants n=27 Participants	31 Participants n=483 Participants	45 Participants n=36 Participants	15 Participants n=10 Participants	128 Participants n=115 Participants
Participants with Diagnosis of Cancer Type Other	3 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	3 Participants n=36 Participants	0 Participants n=10 Participants	9 Participants n=115 Participants
Number of Participants with Mutation Types Anaplastic Lymphoma Kinase (ALK+)	1 Participants n=93 Participants	16 Participants n=4 Participants	6 Participants n=27 Participants	29 Participants n=483 Participants	27 Participants n=36 Participants	5 Participants n=10 Participants	84 Participants n=115 Participants
Number of Participants with Mutation Types Epidermal Growth Factor Receptor (EGFRm)	2 Participants n=93 Participants	1 Participants n=4 Participants	10 Participants n=27 Participants	3 Participants n=483 Participants	18 Participants n=36 Participants	9 Participants n=10 Participants	43 Participants n=115 Participants
Number of Participants with Mutation Types ROS Proto-oncogene 1 (ROS1+)	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants	1 Participants n=10 Participants	4 Participants n=115 Participants
Number of Participants with Mutation Types Other	3 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants
Participants with Prior Chemotherapy Regimen 0	0 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants	12 Participants n=483 Participants	12 Participants n=36 Participants	3 Participants n=10 Participants	36 Participants n=115 Participants
Participants with Prior Chemotherapy Regimen 1	3 Participants n=93 Participants	4 Participants n=4 Participants	3 Participants n=27 Participants	6 Participants n=483 Participants	17 Participants n=36 Participants	2 Participants n=10 Participants	35 Participants n=115 Participants
Participants with Prior Chemotherapy Regimen 2	0 Participants n=93 Participants	9 Participants n=4 Participants	4 Participants n=27 Participants	8 Participants n=483 Participants	10 Participants n=36 Participants	5 Participants n=10 Participants	36 Participants n=115 Participants
Participants with Prior Chemotherapy Regimen > 2	3 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants	6 Participants n=483 Participants	9 Participants n=36 Participants	5 Participants n=10 Participants	30 Participants n=115 Participants
Participants with Prior Radiotherapy to Brain No	6 Participants n=93 Participants	13 Participants n=4 Participants	17 Participants n=27 Participants	24 Participants n=483 Participants	36 Participants n=36 Participants	14 Participants n=10 Participants	110 Participants n=115 Participants
Participants with Prior Radiotherapy to Brain Yes	0 Participants n=93 Participants	5 Participants n=4 Participants	1 Participants n=27 Participants	8 Participants n=483 Participants	12 Participants n=36 Participants	1 Participants n=10 Participants	27 Participants n=115 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety population included all enrolled participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Brigatinib n=137 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Recommended Phase 2 Dose (RP2D) of Brigatinib	NA mg Interval 90.0 to 180.0 RP2D for this study is a dose range.	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)

Population: Full analysis set (FAS) included all participants who received at least one dose of study drug. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Number analyzed is the number of participants with data evaluable for specific category.

ORR assessed by the investigator, is defined as the percentage of the participants with complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) v1.1 after the initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to \<10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (\<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. Crzb=Crizotinib.

Outcome measures

Outcome measures
Measure	Brigatinib n=1 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=14 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=6 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=28 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=25 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=5 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Objective Response Rate (ORR) With Prior Treatment with Crizotinib	0 percentage of participants Interval 0.0 to 0.0	53.8 percentage of participants Interval 25.1 to 80.8	60.0 percentage of participants Interval 14.7 to 94.7	76.0 percentage of participants Interval 54.9 to 90.6	65.2 percentage of participants Interval 42.7 to 83.6	25.0 percentage of participants Interval 0.6 to 80.6	—
Objective Response Rate (ORR) Without Prior Treatment with Crizotinib	—	100.0 percentage of participants Interval 2.5 to 100.0	100.0 percentage of participants Interval 2.5 to 100.0	100.0 percentage of participants Interval 29.2 to 100.0	100.0 percentage of participants Interval 15.8 to 100.0	100.0 percentage of participants Interval 2.5 to 100.0	—

SECONDARY outcome

Timeframe: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)

Population: Safety population included all enrolled participants who received at least one dose of study drug.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Outcome measures

Outcome measures
Measure	Brigatinib n=6 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=18 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=18 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=32 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=48 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=15 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)	6 Participants	18 Participants	18 Participants	32 Participants	48 Participants	15 Participants	—

SECONDARY outcome

Timeframe: Up to Cycle 1 (28 days)

Population: Safety population included all enrolled participants who received at least one dose of study drug. Participants enrolled in the dose escalation phase were included in the analysis.

The MTD is defined as the highest dose at which ≤ 1 of 6 evaluable participants experience a DLT within the first 28 days of treatment (end of Cycle 1).

Outcome measures

Outcome measures
Measure	Brigatinib n=66 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Maximum Tolerated Dose (MTD) Assessed in Dose Escalation Phase of the Study	NA mg MTD criteria was not met.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Cycle 1 (28 days)

Population: DLT-evaluable population included participants who received ≥75% of planned study drug doses during Cycle 1.

DLT include any toxicity that is possibly, probably, or definitely drug-related. Toxicity grades will be defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. DLTs are defined by the following: A) Non-hematologic toxicities: Any grade ≥3 non-hematologic toxicity, with the exception of self-limiting or medically controllable toxicities (eg, nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting \< 3 days, and excluding alopecia. B) Hematologic toxicities: Febrile neutropenia not related to underlying disease (fever, \> 101°F; ANC\<500); Prolonged grade 4 neutropenia (\> 7 days); Neutropenic infection: ≥ grade 3 neutropenia with ≥ grade 3 infection; Thrombocytopenia ≥ grade 3 with bleeding or grade 4 lasting ≥ 7 days. C) Missed ≥ 25% of planned doses of brigatinib over 28 days due to treatment-related AEs in the first cycle.

Outcome measures

Outcome measures
Measure	Brigatinib n=3 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=3 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=5 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=3 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=3 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=6 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg n=2 Participants Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Number of Participants With Dose Limiting Toxicities (DLTs) Assessed in Dose Escalation Phase of the Study	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Cycle 1 (28-days cycle): Day 1

Population: Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here number of participants analyzed is the participants who were evaluable for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.

Outcome measures

Outcome measures
Measure	Brigatinib n=3 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=3 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=50 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=11 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=44 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=10 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg n=2 Participants Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Cmax: Maximum Observed Plasma Concentration for Brigatinib at Cycle 1 Day 1	125.6 ng/mL Standard Deviation 41.07	406.3 ng/mL Standard Deviation 102	493 ng/mL Standard Deviation 289.5	793.7 ng/mL Standard Deviation 828.7	1185 ng/mL Standard Deviation 607.6	1515 ng/mL Standard Deviation 637.9	895 ng/mL Standard Deviation 487.9

SECONDARY outcome

Timeframe: Cycle 2 (28-days cycle): Day 1

Population: Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here number of participants analyzed is the participants with data available for analysis for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.

Outcome measures

Outcome measures
Measure	Brigatinib n=2 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=3 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=15 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=10 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=63 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=7 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Cmax: Maximum Observed Plasma Concentration for Brigatinib at Cycle 2 Day 1	249.50 ng/mL Standard Deviation 167.58	491.67 ng/mL Standard Deviation 223.95	634.07 ng/mL Standard Deviation 310.05	942.30 ng/mL Standard Deviation 472.33	1694.3 ng/mL Standard Deviation 1014.3	2280.0 ng/mL Standard Deviation 1308.5	—

SECONDARY outcome

Timeframe: Cycle 1 (28-days cycle): Day 1

Population: Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, number of participants analyzed is the participants who were evaluable for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.

Outcome measures

Outcome measures
Measure	Brigatinib n=3 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=3 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=50 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=11 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=44 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=10 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg n=2 Participants Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Brigatinib at Cycle 1 Day 1	3.9 hours Interval 3.8 to 4.0	1.0 hours Interval 0.48 to 4.0	2.0 hours Interval 0.48 to 24.0	2.0 hours Interval 0.98 to 6.0	2.0 hours Interval 0.6 to 25.0	2.0 hours Interval 1.0 to 4.0	4.05 hours Interval 4.0 to 4.1

SECONDARY outcome

Timeframe: Cycle 2 (28-days cycle): Day 1

Population: Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, number of participants analyzed is the participants with data available for analyses for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.

Outcome measures

Outcome measures
Measure	Brigatinib n=2 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=3 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=15 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=10 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=63 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=7 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Brigatinib at Cycle 2 Day 1	2.49 hours Interval 0.98 to 4.0	1.00 hours Interval 0.5 to 1.8	2.00 hours Interval 0.98 to 8.0	3.00 hours Interval 0.5 to 6.1	2.10 hours Interval 0.5 to 6.2	2.00 hours Interval 1.0 to 4.0	—

SECONDARY outcome

Timeframe: Cycle 1 (28-days cycle): Day 1 multiple time points (up to 24 hours) post-dose

Outcome measures

Outcome measures
Measure	Brigatinib n=3 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=3 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=15 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=11 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=63 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=7 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg n=2 Participants Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Brigatinib at Cycle 1 Day 1	1320.9 h*ng/mL Standard Deviation 576.29	3900 h*ng/mL Standard Deviation 430.31	5710.1 h*ng/mL Standard Deviation 3268.4	9895.5 h*ng/mL Standard Deviation 11772	13204 h*ng/mL Standard Deviation 6306.9	16800 h*ng/mL Standard Deviation 7571.1	12356 h*ng/mL Standard Deviation 5869

SECONDARY outcome

Timeframe: Cycle 2 (28-days cycle): Day 1 multiple time points (up to 24 hours) post-dose

Population: Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, number of participants analyzed is the participants with data available for analyses for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.

Outcome measures

Outcome measures
Measure	Brigatinib n=2 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=3 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=15 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=10 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=63 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=7 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Brigatinib at Cycle 2 Day 1	2689.0 h*ng/mL Standard Deviation 1145.5	5069.0 h*ng/mL Standard Deviation 1664.7	9142.1 h*ng/mL Standard Deviation 4076.7	13888 h*ng/mL Standard Deviation 7011.4	23478 h*ng/mL Standard Deviation 14463	30117 h*ng/mL Standard Deviation 19921	—

SECONDARY outcome

Timeframe: Cycle 2 (28-days cycle): Day 1

Population: Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, number of participants analyzed is the participants with data available for analyses for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.

Outcome measures

Outcome measures
Measure	Brigatinib n=2 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=3 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=15 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=10 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=63 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=7 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
T1/2: Terminal Phase Elimination Half-life for Brigatinib at Cycle 2 Day 1	31.55 hours Standard Deviation 2.758	30.93 hours Standard Deviation 5.873	28.69 hours Standard Deviation 10.06	25.52 hours Standard Deviation 7.958	24.90 hours Standard Deviation 7.437	21.77 hours Standard Deviation 4.007	—

SECONDARY outcome

Timeframe: Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)

Population: Full analysis set included all participants who received at least one dose of study drug. Participants with ALK and NSCLC were evaluated for this outcome measure. Number analyzed is the number of participants with data evaluable for specific category.

Best overall response is defined as percentage of participants with CR, PR, stable disease (SD) or progressive disease (PD) as per of RECIST v1.1 as evaluated by investigator. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to \<10 mm in short axis. CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (\<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. Disease progression for target lesion: SLD increased by at least 20% from smallest value on study and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. PD for non-target lesion: unequivocal progression of existing non-target lesions. SD for neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	Brigatinib n=1 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=14 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=6 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=28 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=25 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=5 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Best Overall Response With Prior Treatment with Crizotinib: Complete Response	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	12.0 percentage of participants Interval 2.5 to 31.2	8.7 percentage of participants Interval 1.1 to 28.0	0.0 percentage of participants Interval 0.0 to 0.0	—
Best Overall Response Without Prior Treatment with Crizotinib: Complete Response	—	0.0 percentage of participants Interval 0.0 to 0.0	100.0 percentage of participants Interval 2.5 to 100.0	33.3 percentage of participants Interval 0.8 to 90.6	0.0 percentage of participants Interval 0.0 to 0.0	100.0 percentage of participants Interval 2.5 to 100.0	—
Best Overall Response With Prior Treatment with Crizotinib: Partial Response	0.0 percentage of participants Interval 0.0 to 0.0	53.8 percentage of participants Interval 25.1 to 80.8	60.0 percentage of participants Interval 14.7 to 94.7	64.0 percentage of participants Interval 42.5 to 82.0	56.5 percentage of participants Interval 34.5 to 76.8	25.0 percentage of participants Interval 0.6 to 80.6	—
Best Overall Response Without Prior Treatment with Crizotinib: Partial Response	—	100.0 percentage of participants Interval 2.5 to 100.0	0.0 percentage of participants Interval 0.0 to 0.0	66.7 percentage of participants Interval 9.4 to 99.2	100.0 percentage of participants Interval 15.8 to 100.0	0.0 percentage of participants Interval 0.0 to 0.0	—
Best Overall Response With Prior Treatment with Crizotinib: Stable Disease	100.0 percentage of participants Interval 2.5 to 100.0	23.1 percentage of participants Interval 5.0 to 53.8	0.0 percentage of participants Interval 0.0 to 0.0	12.0 percentage of participants Interval 2.5 to 31.2	13.0 percentage of participants Interval 2.8 to 33.6	75.0 percentage of participants Interval 19.4 to 99.4	—
Best Overall Response Without Prior Treatment with Crizotinib: Stable Disease	—	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	—
Best Overall Response With Prior Treatment with Crizotinib: Progressive Disease	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	8.0 percentage of participants Interval 1.0 to 26.0	21.7 percentage of participants Interval 7.5 to 43.7	0.0 percentage of participants Interval 0.0 to 0.0	—
Best Overall Response Without Prior Treatment with Crizotinib: Progressive Disease	—	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)

Population: Full analysis set included all participants who received at least one dose of study drug. Participants who were responders among those who had ALK and NSCLC were evaluated for this outcome measure. Number analyzed is the number of participants with data evaluable for specific category.

Duration of response is defined as time interval from time that measurement criteria are first met for CR/PR (whichever is first recorded) until first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at last valid response assessment.CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to \<10 mm in short axis.CR for non-target lesion:disappearance of all extranodal non-target lesions,all lymph nodes must be non-pathological in size(\<10mm short axis) and normalization of tumor marker level.PR:at least a 30% decrease in SLD of target lesions.PD for target lesion:SLD increased by at least 20% from smallest value and must also demonstrate an absolute increase of \>=5 mm or development of any new lesion.PD for non-target lesion:unequivocal progression of existing non-target lesions.Duration of response calculated by Kaplan-Meier estimation.

Outcome measures

Outcome measures
Measure	Brigatinib All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=8 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=4 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=22 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=17 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=2 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Duration of Response With Prior Treatment with Crizotinib	—	11.1 months Interval 3.8 to 16.7	4.0 months Interval 3.7 to 29.5	14.8 months Interval 7.9 to 25.1	20.4 months Interval 7.5 to 51.6	29.7 months 95% CI was not estimable due to low number of participants with events.	—
Duration of Response Without Prior Treatment with Crizotinib	—	30.4 months 95% CI was not estimable due to low number of participants with events.	60.3 months 95% CI was not estimable due to low number of participants with events.	52.0 months Interval 5.6 to 52.0	20.8 months Interval 9.2 to 32.4	NA months Duration of response was not estimable due to low number of participants with events.	—

SECONDARY outcome

Timeframe: Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)

Population: Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, overall number of participants analyzed is the participants who were evaluable for this outcome measure.

PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. Disease progression for target lesion: SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest) and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. Disease progression for non-target lesion: Unequivocal progression of existing non-target lesions. (Subjective judgment by experienced reader).

Outcome measures

Outcome measures
Measure	Brigatinib n=5 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=15 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=17 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=21 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=40 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=7 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Progression Free Survival (PFS)	1.8 months Interval 1.0 to 5.5	12.6 months Interval 0.9 to 47.9	5.4 months Interval 0.8 to 63.9	11.0 months Interval 0.5 to 53.6	5.4 months Interval 0.1 to 69.9	5.4 months Interval 1.8 to 31.5	—

SECONDARY outcome

Timeframe: Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)

OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause.

Outcome measures

Outcome measures
Measure	Brigatinib n=6 Participants All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=11 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=12 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=17 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=25 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=11 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Overall Survival (OS)	5.3 months Interval 2.3 to 12.6	11.6 months Interval 4.0 to 47.6	7.3 months Interval 0.5 to 28.6	17.9 months Interval 1.4 to 35.0	7.3 months Interval 0.1 to 55.0	8.3 months Interval 3.3 to 22.3	—

SECONDARY outcome

Timeframe: Screening and at 8-week intervals thereafter (approximately up to 50 months)

Population: Full analysis set. ALK+ NSCLC participants with measurable and non-measurable brain metastases at baseline were evaluated for this outcome measure. Here, number analyzed is the number of participants who were evaluable for specific category.

Intracranial objective response rate is defined as the percentage of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 after the initiation of study drug. CR for target lesion: disappearance of all extranodal lesions. CR for non-target lesion: disappearance of all extranodal non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Brigatinib All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=8 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=1 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=18 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=16 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=3 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Intracranial Objective Response Rate Measurable Brain Metastases	—	100 percentage of participants Interval 15.8 to 100.0	—	80 percentage of participants Interval 28.4 to 99.5	42.9 percentage of participants Interval 9.9 to 81.6	100 percentage of participants Interval 2.5 to 100.0	—
Intracranial Objective Response Rate Only Non-Measurable Brain Metastases	—	16.7 percentage of participants Interval 0.4 to 64.1	100 percentage of participants Interval 2.5 to 100.0	46.2 percentage of participants Interval 19.2 to 74.9	44.4 percentage of participants Interval 13.7 to 78.8	50.0 percentage of participants Interval 1.3 to 98.7	—

SECONDARY outcome

Timeframe: Screening and at 8-week intervals thereafter (approximately up to 50 months)

Population: Full analysis set. ALK+ NSCLC participants with measurable and non-measurable brain metastases at baseline were evaluated for this outcome measure.

Intracranial duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR in brain metastases (whichever is first recorded) until the first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at the last valid response assessment. Duration intracranial of response was calculated by Kaplan-Meier estimation.

Outcome measures

Outcome measures
Measure	Brigatinib All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=8 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=1 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=18 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=16 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=3 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Duration of Intracranial Response	—	12.9 months Upper and lower limit of duration of intracranial response was not reached due to low number of participants with events.	5.0 months Upper and lower limit of duration of intracranial response was not reached due to low number of participants with events.	11.4 months Interval 7.5 to 11.4	29.2 months Interval 5.5 to 29.2	11.3 months Interval 3.6 to 18.9	—

SECONDARY outcome

Timeframe: Screening and at 8-week intervals thereafter (approximately up to 50 months)

Population: Full analysis set. ALK+ NSCLC participants with measurable and non-measurable brain metastases at baseline were evaluated for this outcome measure.

PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression in brain, or death due to any cause, whichever occurs first. Intracranial PFS was calculated by Kaplan-Meier estimation.

Outcome measures

Outcome measures
Measure	Brigatinib All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=8 Participants Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=1 Participants Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=18 Participants Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=16 Participants Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=3 Participants Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 300 mg Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Intracranial Progression Free Survival (PFS)	—	36.8 months Interval 5.5 to 36.8	6.7 months Upper limit of 95% CI was not reached due to low number of participants with events.	NA months Interval 9.4 to Progression-free survival was not reached due to low number of participants with events.	14.4 months Interval 7.3 to 31.1	7.3 months Interval 3.1 to 22.3	—

Adverse Events

Brigatinib 30 mg QD/60 mg QD

Serious events: 1 serious events

Other events: 6 other events

Deaths: 6 deaths

Brigatinib 90 mg QD

Serious events: 10 serious events

Other events: 17 other events

Deaths: 11 deaths

Brigatinib 120 mg QD/60 mg BID

Serious events: 10 serious events

Other events: 17 other events

Deaths: 12 deaths

Brigatinib 90 mg QD-180 mg QD

Serious events: 14 serious events

Other events: 31 other events

Deaths: 17 deaths

Brigatinib 180 mg QD/90 mg BID

Serious events: 30 serious events

Other events: 45 other events

Deaths: 25 deaths

Brigatinib 240 mg QD/120 mg BID/300 mg QD

Serious events: 11 serious events

Other events: 15 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Brigatinib 30 mg QD/60 mg QD n=6 participants at risk Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=18 participants at risk Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=18 participants at risk Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=32 participants at risk Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=48 participants at risk Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=15 participants at risk Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
General disorders Sudden death	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Oesophageal compression	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Rectal ulcer	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Atrial fibrillation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Supraventricular tachycardia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Cardiac failure congestive	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Cardiac tamponade	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Angina unstable	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Tachycardia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Pancreatitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Bezoar	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Colitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Influenza like illness	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	26.7% 4/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Pneumonia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Bronchitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Sepsis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Device related infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Device related sepsis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Atypical mycobacterial lower respiratory tract infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Pneumonia pseudomonal	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Urinary tract infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Viral infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Seizure	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Syncope	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Central nervous system haemorrhage	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Cerebral haemorrhage	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Cognitive disorder	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Embolic stroke	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Haemorrhage intracranial	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Haemorrhagic stroke	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Headache	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Ischaemic stroke	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Nervous system disorder	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Transient ischaemic attack	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Non-cardiac chest pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Pyrexia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Death	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Failure to thrive	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Insulin resistance	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Mental status changes	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Confusional state	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Suicidal ideation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Radiation necrosis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Radiation pneumonitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Alanine aminotransferase increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Aspartate aminotransferase increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Vascular disorders Haematoma	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Immune system disorders Food allergy	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia recurrent	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile squamous cell carcinoma	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Cellulitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Respiratory tract infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Ataxia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Central nervous system lesion	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Cerebral ischaemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Dysarthria	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Hydrocephalus	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Presyncope	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Status epilepticus	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Cardio-respiratory arrest	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Pericardial effusion	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Femur fracture	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Radiation associated cardiac failure	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Blindness	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)

Other adverse events

Other adverse events
Measure	Brigatinib 30 mg QD/60 mg QD n=6 participants at risk Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD n=18 participants at risk Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 120 mg QD/60 mg BID n=18 participants at risk Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 90 mg QD-180 mg QD n=32 participants at risk Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).	Brigatinib 180 mg QD/90 mg BID n=48 participants at risk Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).	Brigatinib 240 mg QD/120 mg BID/300 mg QD n=15 participants at risk Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Dysphagia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Aphthous ulcer	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Nausea	50.0% 3/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	44.4% 8/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	50.0% 9/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	50.0% 16/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	68.8% 33/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	53.3% 8/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	44.4% 8/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	38.9% 7/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	53.1% 17/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	43.8% 21/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	53.3% 8/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Constipation	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	33.3% 6/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	27.8% 5/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	28.1% 9/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 8/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	26.7% 4/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Vomiting	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	27.8% 5/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	28.1% 9/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	39.6% 19/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	33.3% 5/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Abdominal pain	50.0% 3/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 6/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Dry mouth	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	15.6% 5/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Flatulence	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Stomatitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Cheilitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Mouth ulceration	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Abdominal rigidity	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 6/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Lip dry	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Lip swelling	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Oesophageal irritation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Oesophageal pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Toothache	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Fatigue	33.3% 2/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	50.0% 9/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	50.0% 9/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	50.0% 16/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	39.6% 19/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	80.0% 12/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Oedema peripheral	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 6/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	26.7% 4/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Pyrexia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 6/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	14.6% 7/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Chest discomfort	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Non-cardiac chest pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Influenza like illness	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Asthenia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Chills	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Gait disturbance	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Peripheral swelling	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Chest pain	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Thirst	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Axillary pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Exercise tolerance decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Feeling abnormal	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Feeling jittery	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	38.9% 7/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	33.3% 6/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	40.6% 13/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	29.2% 14/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	53.3% 8/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	27.8% 5/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	21.9% 7/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.8% 10/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	26.7% 4/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	15.6% 5/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Sinus congestion	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Respiratory tract irritation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Immune system disorders Seasonal allergy	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Immune system disorders Contrast media allergy	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Reproductive system and breast disorders Nipple pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Endocrine disorders Hypothyroidism	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Ear and labyrinth disorders Tinnitus	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Ear and labyrinth disorders Deafness unilateral	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Ear and labyrinth disorders Vertigo	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Sinus tachycardia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Palpitations	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Sinus bradycardia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Atrial fibrillation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Atrial flutter	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Cardiac disorders Cardiac failure congestive	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	15.6% 5/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Rib fracture	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Procedural pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Radiation neuropathy	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Radiation pneumonitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Renal and urinary disorders Pollakiuria	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Renal and urinary disorders Proteinuria	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Renal and urinary disorders Haematuria	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Renal and urinary disorders Dysuria	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Renal and urinary disorders Renal failure	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Renal and urinary disorders Urinary retention	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Vascular disorders Hypertension	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	33.3% 6/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	34.4% 11/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.8% 10/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Vascular disorders Hypotension	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Vascular disorders Deep vein thrombosis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Vascular disorders Vascular pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Insomnia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 6/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 6/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Anxiety	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	15.6% 5/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Depression	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Bruxism	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Anticipatory anxiety	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Confusional state	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Disorientation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Nervousness	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Psychiatric disorders Stress	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Vision blurred	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 6/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Dry eye	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Visual impairment	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Blepharospasm	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Lacrimation increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Photopsia	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Vitreous floaters	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Asthenopia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Cataract	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Eye pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Eyelid margin crusting	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	37.5% 12/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	14.6% 7/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Nasopharyngitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	15.6% 5/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	14.6% 7/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Urinary tract infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 6/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 9/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Sinusitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	26.7% 4/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Pneumonia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Bronchitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Influenza	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Oral candidiasis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Viral infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Conjunctivitis viral	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Diarrhoea infectious	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Folliculitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Fungal skin infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Infectious pleural effusion	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Laryngitis viral	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Nail infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Nasal herpes	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Onychomycosis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Otitis externa	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Paronychia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Skin candida	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Vaginal infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	21.9% 7/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Nail growth abnormal	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	27.8% 5/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	31.2% 10/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	25.0% 12/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	33.3% 5/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	21.9% 7/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	15.6% 5/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Increased appetite	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Amylase increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	27.8% 5/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	27.8% 5/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	31.2% 10/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 9/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Lipase increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	27.8% 5/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	37.5% 12/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 6/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Aspartate aminotransferase increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	38.9% 7/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	31.2% 10/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 9/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Alanine aminotransferase increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 6/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood insulin increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Weight decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	15.6% 5/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 6/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood creatine phosphokinase increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Lymphocyte count decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Weight increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood alkaline phosphatase increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood testosterone decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood bilirubin increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood lactate dehydrogenase increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood thyroid stimulating hormone increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Activated partial thromboplastin time prolonged	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Electrocardiogram QT prolonged	33.3% 2/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Bacterial test positive	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Ejection fraction decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Heart rate increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Urinary sediment present	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Urine leukocyte esterase positive	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations White blood cells urine positive	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Muscle spasms	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	25.0% 8/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	27.1% 13/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	27.8% 5/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	34.4% 11/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.8% 10/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 8/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.0% 3/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	31.2% 10/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	20.8% 10/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	16.7% 3/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	33.3% 2/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	15.6% 5/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	22.2% 4/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 6/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Bone pain	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 6/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	15.6% 5/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Arthritis	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Fracture pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Headache	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	44.4% 8/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	38.9% 7/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	43.8% 14/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	37.5% 18/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	40.0% 6/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Dizziness	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	27.8% 5/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	15.6% 5/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	18.8% 6/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Paraesthesia	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Dysgeusia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Tremor	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	9.4% 3/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Amnesia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Balance disorder	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Hypoaesthesia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Visual field defect	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	10.4% 5/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Seizure	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	13.3% 2/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Aphasia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Disturbance in attention	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Dysarthria	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Memory impairment	16.7% 1/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Sinus headache	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Somnolence	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Syncope	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Burning sensation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Cognitive disorder	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Neuralgia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Parosmia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Peripheral motor neuropathy	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Hyperaesthesia teeth	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Eructation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Abnormal faeces	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Enterocolitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Gastrointestinal disorders Haematochezia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Swelling face	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Mucosal inflammation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Swelling	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
General disorders Temperature intolerance	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Taste disorder	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Neuropathy peripheral	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Presyncope	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Nervous system disorders Dizziness postural	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Gout	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood creatinine increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 3/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood alkaline phosphatase decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood magnesium decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood phosphorus decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Blood sodium increased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Electrocardiogram T wave abnormal	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Haematocrit decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations Haemoglobin decreased	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	11.1% 2/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	8.3% 4/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Eczema nummular	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Cellulitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Gastroenteritis viral	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Rhinitis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Ear infection bacterial	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Kidney infection	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Oral herpes	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Vulvovaginal candidiasis	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Infections and infestations Herpes zoster	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Vascular disorders Hot flush	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Eyelid oedema	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Dyschromatopsia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Eye swelling	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Renal and urinary disorders Urinary tract pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Fall	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	12.5% 4/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	4.2% 2/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.2% 2/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Foot fracture	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Ear and labyrinth disorders Ear discomfort	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Ear and labyrinth disorders Ear pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Endocrine disorders Hyperthyroidism	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dysplastic naevus	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Reproductive system and breast disorders Metrorrhagia	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	3.1% 1/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Reproductive system and breast disorders Breast pain	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	2.1% 1/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Eye disorders Cataract cortical	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	6.7% 1/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Investigations White blood cell count increased.	0.00% 0/6 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	5.6% 1/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/18 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/32 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/48 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)	0.00% 0/15 • All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER